Home › NDC Lookup › Ingredients › Tirzepatide › 00002-6103-11
Zepbound tirzepatide 8.33 mg/mL Injection, Solution, 1 vial — NDC 00002-6103-11 package photo

Zepbound tirzepatide 8.33 mg/mL Injection, Solution, 1 vial

by Eli Lilly and Company · 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6103-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6103-01)
NDC 00002-6103-11
🏷️ FDA NDC (as labeled) 0002-6103-11 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0002-6103-11
Product NDC 0002-6103
11-digit billing NDC 00002610311
UNII OYN3CCI6QE
UPC 0300022002045, 0300026210118, 0300021423049, 0300020152049 +8 more
Application # NDA217806
SPL Set ID 487cd7e7-434c-4925-99fa-aa80b1cc776b
Established class (EPC) Glucose-dependent Insulinotropic Polypeptide Receptor Agonist; GLP-1 Receptor Agonist
Mechanism of action G-Protein-linked Receptor Interactions; Glucagon-like Peptide-1 (GLP-1) Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-07
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance TIRZEPATIDE
Why two NDCs? The FDA registers this code as 0002-6103-11 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00002-6103-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerEli Lilly and Company
Application holderELI LILLY AND CO
FDA applicationNDA217806 (NDA)
Labeler code00002
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio192 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Tirzepatide is a once-weekly injectable medication that works on two hormone receptors — GIP and GLP-1 — that your body uses to control appetite and blood sugar. Zepbound, the bran...
  • What exactly is tirzepatide, and what is it used for?
  • You inject it just under the skin — in your belly, thigh, or, if someone else is doing it, the back of your upper arm — once a week. You can do it any day, at any time, with or wit...
  • How do I take this injection, and does it matter what time of day I do it?
📖 Read our full Tirzepatide injection guide →
1
Nutrient depletion considerations

Tirzepatide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tirzepatide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 9 mg / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 8 mg / 1 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 1.80 mg / 1 mL UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • 1.75 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 1.34 mg / 1 mL UNII 70WT22SF4B
    A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $539.70 $1,295.28 / 2.4 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zepbound KwikPen 8.33 mg/mL 00002-3555-11 Eli 1 syringe $200.902 — Availability likely —
Mounjaro 8.33 mg/mL 00002-4103-11 Eli 1 vial — — FDA listed —
Zepbound 8.33 mg/mLthis 00002-6103-11 Eli 1 vial — — FDA listed —
Mounjaro KwikPen 8.33 mg/mL 00002-3455-11 Eli 1 syringe — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
First FDA approval
Mar 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 28, 2024 RLD RS ⏳ ~12.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4308)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4228)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 12343382 — method of use (U-4227)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4410)
US 12343382 — method of use (U-4409)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4311)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4310)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4309)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 12453758 — method of use (U-4308)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 11918623 — method of use (U-3855)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12616740 — method of use (U-4497)
US 12616740 — method of use (U-4498)
US 12616740 — method of use (U-4499)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 12629404 — method of use (U-4531)
US 12629404 — method of use (U-4532)
US 11357820 — drug product
US 9474780 — drug substance
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US 9474780 — drug substance
US 11357820 — drug product
US 12453756 — drug product
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US 11357820 — drug product
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US 9474780 — drug substance
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US 12453756 — drug product
US 9474780 — drug substance
US 9474780 — drug substance
US 12453756 — drug product
US 11357820 — drug product
US 11357820 — drug product
US 9474780 — drug substance
US 9474780 — drug substance
US 9474780 — drug substance
US 11357820 — drug product
US 11357820 — drug product
US 12453756 — drug product
US 12453756 — drug product
US 9474780 — drug substance
US 12453756 — drug product
US 12453756 — drug product
US 11357820 — drug product
US 12453756 — drug product
US 12453756 — drug product
US 9474780 — drug substance
US 9474780 — drug substance
US 9474780 — drug substance
US 9474780 — drug substance
US 9474780 — drug substance
US 9474780 — drug substance
US 11357820 — drug product
US 11357820 — drug product
US 12453756 — drug product
US 12453756 — drug product
US 11357820 — drug product
US 11357820 — drug product
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity NP
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity NP
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity NP
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity NP
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity NP
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity NP
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
Exclusivity I-958
Exclusivity M-82
Exclusivity NCE
2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (348)
PatentTypeUse codeExpires
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4228 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 12343382 ↗ Method of use U-4227 Jul 22, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4410 Jul 22, 2039
US 12343382 ↗ Method of use U-4409 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4311 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4310 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4309 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 12453758 ↗ Method of use U-4308 Jul 22, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 11918623 ↗ Method of use U-3855 Jun 14, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12616740 ↗ Method of use U-4497 Jul 22, 2039
US 12616740 ↗ Method of use U-4498 Jul 22, 2039
US 12616740 ↗ Method of use U-4499 Jul 22, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 12629404 ↗ Method of use U-4531 Jun 14, 2039
US 12629404 ↗ Method of use U-4532 Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 12453756 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 11357820 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 11357820 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 12453756 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 12453756 ↗ Drug product — Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 11357820 ↗ Drug product — Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 12453756 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 9474780 ↗ Drug substance — May 13, 2036
US 11357820 ↗ Drug product — Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 12453756 ↗ Drug product — Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
US 11357820 ↗ Drug product — Jun 14, 2039
FDA exclusivity
CodeWhat it grantsExpires
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
NPNew ProductNov 8, 2026
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
NPNew ProductNov 8, 2026
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
NPNew ProductNov 8, 2026
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
NPNew ProductNov 8, 2026
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
NPNew ProductNov 8, 2026
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
NPNew ProductNov 8, 2026
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
I-958New indication (3-year)Dec 20, 2027
M-82New indication / labeling change (3-year)Oct 18, 2027
NCENew Chemical Entity (5-year)May 13, 2027
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2039 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Zepbound — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zepbound. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$494.09M
Claims incl. refills
439.4K
Beneficiaries
180.1K
Spend / beneficiary
$2,742.82
Spend / claim
$1,124.51
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00002-6103-11 You're viewing this 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6103-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6103-01) 2026-01-07 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0002-6103-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00002-6103-11, written without dashes as 00002610311. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00002-6103-11, the first segment (00002) is the labeler code FDA assigned to Eli Lilly and Company; the middle segment (6103) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eli Lilly and Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eli Lilly and Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] .

Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.

In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

🎯 Indications and Usage 175 words ▾

1 INDICATIONS AND USAGE ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.

( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide.

Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dose Escalation Schedule The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. ( 2.1 ) Consider treatment response and tolerability when selecting the maintenance dosage.

( 2.1 ) Recommended Maintenance and Maximum Dosage Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. ( 2.2 ) Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. ( 2.2 ) Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly.

( 2.2 ) Administration Instructions Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. ( 2.4 )

2.1Recommended Dose Escalation Schedule The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage. Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] .

After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose [see Dosage and Administration ( 2.2 )] . Consider treatment response and tolerability when selecting the maintenance dosage.

If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage.

2.2Recommended Maintenance and Maximum Dosage Recommended Maintenance Dosage Weight Reduction and Long-Term Maintenance The recommended maintenance dosage is 5 mg, 10 mg, or 15 mg, injected subcutaneously once weekly. OSA The recommended maintenance dosage is 10 mg or 15 mg injected subcutaneously once weekly. Maximum Recommended Dosage The maximum dosage of ZEPBOUND for all indications is 15 mg injected subcutaneously once weekly.

2.3Recommendations Regarding Missed Dose If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours).

2.4Important Administration Instructions Inform patients and their caregiver(s) which ZEPBOUND presentation (e.g., vial, prefilled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed ZEPBOUND presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed ZEPBOUND presentation [see Instructions for Use ] .

After training, a patient may self-inject ZEPBOUND if the healthcare provider determines that it can be properly administered, except for the following: ZEPBOUND KwikPen is not recommended for self-administration by those who are visually impaired. Instruct patients using ZEPBOUND vials to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) and always use a new syringe and needle for each injection. Inspect ZEPBOUND visually before use.

It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen. Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity.

Administer ZEPBOUND onc…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Injection: Clear, colorless to slightly yellow solution in pre-filled single-dose pens, single-dose vials, multi-dose vials, or single-patient-use KwikPens, each available in the following strengths. The multi-dose vials and single-patient-use KwikPen each contain 4 doses: Single-dose Pen or Vial 2.5 mg/0.5 mL 5 mg/0.5 mL 7.5 mg/0.5 mL 10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mL Multi-dose Vial (4 doses per vial) Dose per Injection Total Strength per Total Volume Strength per mL 2.5 mg/0.6 mL 10 mg/2.4 mL 4.17 mg/mL 5 mg/0.6 mL 20 mg/2.4 mL 8.33 mg/mL 7.5 mg/0.6 mL 30 mg/2.4 mL 12.5 mg/mL 10 mg/0.6 mL 40 mg/2.4 mL 16.7 mg/mL 12.5 mg/0.6 mL 50 mg/2.4 mL 20.8 mg/mL 15 mg/0.6 mL 60 mg/2.4 mL 25 mg/mL Single-Patient-Use KwikPen (4 doses per KwikPen) Dose per Injection Total Strength per Total Volume Strength per mL 2.5 mg 10 mg/2.4 mL 4.17 mg/mL 5 mg 20 mg/2.4 mL 8.33 mg/mL 7.5 mg 30 mg/2.4 mL 12.5 mg/mL 10 mg 40 mg/2.4 mL 16.7 mg/mL 12.5 mg 50 mg/2.4 mL 20.8 mg/mL 15 mg 60 mg/2.4 mL 25 mg/mL Injection: Single-dose pen or single-dose vial: 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, or 15 mg/0.5 mL ( 3 ) Multi-dose vial or single-patient-use KwikPen ® : 10 mg/2.4 mL (4.17 mg/mL) for four 2.5 mg/0.6 mL doses, 20 mg/2.4 mL (8.33 mg/mL) for four 5 mg/0.6 mL doses, 30 mg/2.4 mL (12.5 mg/mL) for four 7.5 mg/0.6 mL doses, 40 mg/2.4 mL (16.7 mg/mL) for four 10 mg/0.6 mL doses, 50 mg/2.4 mL (20.8 mg/mL) for four 12.5 mg/0.6 mL doses, or 60 mg/2.4 mL (25 mg/mL) for four 15 mg/0.6 mL ( 3 )

⛔ Contraindications 103 words ▾

4 CONTRAINDICATIONS ZEPBOUND is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )] .

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 ( 4 ) Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. ( 5.2 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.

( 5.3 ) Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.4 ) Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND.

Discontinue if pancreatitis is suspected. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND.

( 5.6 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

( 5.7 ) Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Monitor patients with a history of diabetic retinopathy for progression. ( 5.8 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

( 5.9 ) Never share a ZEPBOUND KwikPen between patients, even if the pen needle is changed. ( 5.10 )

5.1Risk of Thyroid C-Cell Tumors In rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2.

Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease.

Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2Severe Gastrointestinal Adverse Reactions Use of ZEPBOUND has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions ( 6 )] . In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), severe gastrointestinal adverse reactions were reported more frequently among patients receiving ZEPBOUND (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1%). Similar rates of severe gastrointestinal adverse reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND clinical trials for OSA.

Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. ZEPBOUND is not recommended in patients with severe gastroparesis.

5.3 Acute Kidney Injury Due to…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in ≥5% of patients treated with ZEPBOUND are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Patients for Weight Reduction and Long-Term Maintenance Pool of Placebo - Controlled Weight Reduction Trials in Adults with Obesity or Overweight, with or without Type 2 Diabetes (Study 1 and Study 2) ZEPBOUND was evaluated for safety in a pool of two randomized, double-blind, placebo-controlled trials that included 2,519 adult patients with obesity or overweight treated with ZEPBOUND for up to 72 weeks and a 4-week off drug follow-up period (Study 1 and Study 2) [see Clinical Studies ( 14.1 )] .

The mean age of patients was 47 years and 37% were male. The population was 72% White, 12% Asian, 8% Black or African American, and 7% American Indian or Alaska Native; 51% identified as Hispanic or Latino ethnicity. Baseline characteristics included an average BMI of 37.4 kg/m 2 , 29% with a BMI ≥40 kg/m 2 , 41% with hypertension, 37% with dyslipidemia, 25% with type 2 diabetes mellitus, 7% with obstructive sleep apnea, and 4% with cardiovascular (CV) disease.

Across both trials, 4.8%, 6.3%, and 6.7% of patients treated with 5 mg, 10 mg, and 15 mg of ZEPBOUND, respectively, permanently discontinued treatment as a result of adverse reactions compared to 3.4% of patients treated with placebo. The majority of patients who discontinued ZEPBOUND due to adverse reactions did so during the first few months of treatment due to gastrointestinal adverse reactions. Common Adverse Reactions Table 1 shows common adverse reactions associated with the use of ZEPBOUND in the pool of two placebo-controlled trials for weight reduction (Study 1 and Study 2).

These adverse reactions occurred more commonly with ZEPBOUND than with placebo and occurred in at least 2% of patients treated with ZEPBOUND. Table 1: Adverse Reactions (≥2% and Greater than Placebo) in ZEPBOUND-Treated Adults with Obesity or Overweight in Weight Reduction and Long-term Maintenance Trials (Study 1 and Study 2) a Includes diarrhea, frequent bowel movements. b Includes constipation, feces hard. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness. d Includes multiple related adverse event terms, such as injection site bruising, injection site erythema, injection site pruritus, injection site pain, injection site rash, injection site reaction. e Includes asthenia, fatigue, lethargy, malaise. f Includes blood pressure decreased, hypotension, orthostatic hypotension.

Adverse Reaction…

🔄 Drug Interactions 189 words ▾

7 DRUG INTERACTIONS ZEPBOUND delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. ( 7.2 )

7.1Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea) ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.7 )] .

7.2Oral Medications ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND.

Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected [see Use in Specific Populations ( 8.3 ) and Clinical Pharmacology ( 12.2 , 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND. ( 8.1 ) Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation. ( 8.3 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZEPBOUND (tirzepatide) during pregnancy. Pregnant patients exposed to ZEPBOUND and healthcare providers are encouraged to register by calling 1-844-524-0039 or emailing at [email protected]. To learn more please call or visit https://pregnancyregistry.lilly.com/zepbound.

Risk Summary Weight loss offers no benefit to a pregnant patient and may cause fetal harm. Advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue ZEPBOUND when a pregnancy is recognized (see Clinical Considerations) . Available data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC.

These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is increased when compared to the general population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those with obesity or overweight, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. Data Animal Data In pregnant rats given twice weekly subcutaneous doses of 0.02, 0.1, and 0.5 mg/kg tirzepatide [0.03-, 0.07-, and 0.5-fold the maximum recommended human dose (MRHD) of 15 mg once weekly based on AUC] during organogenesis, increased incidences of external, visceral, and skeletal malformations, increased incidences of visceral and skeletal developmental variations, and decreased fetal weights coincided with pharmacologically-mediated reductions in maternal body weights and food consumption at 0.5 mg/kg.

In pregnant rabbits given once weekly subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg tirzepatide (0.01-, 0.06-, and 0.2-fold the MRHD) during organogenesis, pharmacologically mediated effects on the gastrointestinal system resulting in maternal mortality or abortion in a few rabbits occurred at all dose levels. Reduced fetal weights associated with decreased maternal food consumption and body weights were observed at 0.1 mg/kg. In a pre- and post-natal study in rats administered subcutaneous doses of 0.02, 0.10, or 0.25 mg/kg tirzepatide twice weekly from implantation through lactation, F 1 pups from F 0 maternal rats given 0.25 mg/kg tirzepatide had statistically significant lower mean body weight when compared to controls from post-natal day 7 through post-natal day 126 for males and post-natal day 56 for females.

8.2Lactation Risk Summary In a single-dose clinical lactation study, the concentration of tirzepatide in breast milk was found to be either undetectable or low compared to the maternal administered dose (see…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZEPBOUND (tirzepatide) during pregnancy. Pregnant patients exposed to ZEPBOUND and healthcare providers are encouraged to register by calling 1-844-524-0039 or emailing at [email protected]. To learn more please call or visit https://pregnancyregistry.lilly.com/zepbound.

Risk Summary Weight loss offers no benefit to a pregnant patient and may cause fetal harm. Advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue ZEPBOUND when a pregnancy is recognized (see Clinical Considerations) . Available data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC.

These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is increased when compared to the general population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those with obesity or overweight, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. Data Animal Data In pregnant rats given twice weekly subcutaneous doses of 0.02, 0.1, and 0.5 mg/kg tirzepatide [0.03-, 0.07-, and 0.5-fold the maximum recommended human dose (MRHD) of 15 mg once weekly based on AUC] during organogenesis, increased incidences of external, visceral, and skeletal malformations, increased incidences of visceral and skeletal developmental variations, and decreased fetal weights coincided with pharmacologically-mediated reductions in maternal body weights and food consumption at 0.5 mg/kg.

In pregnant rabbits given once weekly subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg tirzepatide (0.01-, 0.06-, and 0.2-fold the MRHD) during organogenesis, pharmacologically mediated effects on the gastrointestinal system resulting in maternal mortality or abortion in a few rabbits occurred at all dose levels. Reduced fetal weights associated with decreased maternal food consumption and body weights were observed at 0.1 mg/kg. In a pre- and post-natal study in rats administered subcutaneous doses of 0.02, 0.10, or 0.25 mg/kg tirzepatide twice weekly from implantation through lactation, F 1 pups from F 0 maternal rats given 0.25 mg/kg tirzepatide had statistically significant lower mean body weight when compared to controls from post-natal day 7 through post-natal day 126 for males and post-natal day 56 for females.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of ZEPBOUND have not been established in pediatric patients.

🧓 Geriatric Use 120 words ▾

8.5Geriatric Use In a pool of two fixed dose ZEPBOUND clinical studies for weight reduction (Study 1 and Study 2), 226 (9%) ZEPBOUND-treated patients were 65 years of age or older, and 13 (0.5%) ZEPBOUND-treated patients were 75 years of age or older at baseline. No overall differences in safety or effectiveness of ZEPBOUND have been observed between patients 65 years of age and older and younger adult patients. ZEPBOUND clinical studies in OSA (Study 5 and Study 6) did not include sufficient numbers of patients age 65 years or older to determine whether they respond differently from younger adult patients.

Other reported clinical experience with tirzepatide has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 60 words ▾

10 OVERDOSAGE In the event of an overdosage, contact the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of tirzepatide of approximately 5 days.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1.

GLP-1 is a physiological regulator of appetite and caloric intake. Nonclinical studies suggest the addition of GIP may further contribute to the regulation of food intake. Both GIP receptors and GLP-1 receptors are found in areas of the brain involved in appetite regulation.

Animal studies show that tirzepatide distributes to and activates neurons in brain regions involved in regulation of appetite and food intake.

12.2Pharmacodynamics Tirzepatide lowers body weight with greater fat mass loss than lean mass loss. Tirzepatide decreases calorie intake. The effects are likely mediated by affecting appetite.

Tirzepatide stimulates insulin secretion in a glucose-dependent manner and reduces glucagon secretion. Tirzepatide increases insulin sensitivity, as demonstrated in a hyperinsulinemic euglycemic clamp study in patients with type 2 diabetes mellitus after 28 weeks of treatment. These effects can lead to a reduction of blood glucose.

Tirzepatide delays gastric emptying. The delay is largest after the first dose and this effect diminishes over time.

12.3Pharmacokinetics The pharmacokinetics of tirzepatide is similar between healthy subjects, patients with overweight or obesity, and patients with OSA and obesity. Steady-state plasma tirzepatide concentrations were achieved following 4 weeks of once weekly administration. Tirzepatide exposure increases in a dose-proportional manner.

Absorption Following subcutaneous administration, the median time (range) to maximum plasma concentration of tirzepatide is 24 hours (8 to 72 hours). The mean absolute bioavailability of tirzepatide following subcutaneous administration is 80%. Similar exposure was achieved with subcutaneous administration of tirzepatide in the abdomen, thigh, or upper arm.

Distribution The mean [coefficient of variation (CV)%] apparent steady-state volumes of distribution of tirzepatide following subcutaneous administration in patients with overweight or obesity and patients with OSA and obesity are approximately

9.7 L (29%) and

11.8L (37%), respectively. Tirzepatide is highly bound to plasma albumin (99%). Elimination The apparent population mean clearance of tirzepatide in patients with overweight or obesity and patients with OSA and obesity is approximately

0.06L/h (CV% ~ 20%). The elimination half-life is approximately 5-6 days in patients with overweight or obesity, and in patients with OSA and obesity. Metabolism Tirzepatide is metabolized by proteolytic cleavage of the peptide backbone, beta-oxidation of the C20 fatty diacid, and amide hydrolysis.

Excretion The primary excretion routes of tirzepatide metabolites are via urine and feces. Intact tirzepatide is not observed in urine or feces. Specific Populations The intrinsic factors of age (18 to 84 years), sex, race (71% White, 11% Asian, 9% American Indian or Alaska Native, and 8% Black or African American), ethnicity, or body weight do not have a clinically relevant effect on the PK of tirzepatide.

Patients with Renal Impairment Renal impairment does not impact the pharmacokinetics of tirzepatide. The pharmacokinetics of tirzepatide after a single 5 mg dose were evaluated in patients with different degrees of renal impairment (mild, moderate, severe, ESRD) compared with subjects with normal renal function. Data from clinical studies have also shown that renal impairment in patients with overweight or obesity does not impact the pharmacokinetics of tirzepatide [see Use in Specific Populations ( 8.6 )] .

Patients with Hepatic Impairment Hepatic impairment does not impact the pharmacokinetics of tirzepatide. The pharmacokinetics of tirzepatide after a single 5 mg dose were evaluated in patients with…

🧬 Mechanism of Action 110 words ▾

12.1Mechanism of Action Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1.

GLP-1 is a physiological regulator of appetite and caloric intake. Nonclinical studies suggest the addition of GIP may further contribute to the regulation of food intake. Both GIP receptors and GLP-1 receptors are found in areas of the brain involved in appetite regulation.

Animal studies show that tirzepatide distributes to and activates neurons in brain regions involved in regulation of appetite and food intake.

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4 mL (8.33 mg/mL) 0002-6103-11 4 doses of 7.5 mg/0.6 mL 30 mg/2.4 mL (12.5 mg/mL) 0002-6210-11 4 doses of 10 mg/0.6 mL 40 mg/2.4 mL (16.7 mg/mL) 0002-6304-11 4 doses of 12.5 mg/0.6 mL 50 mg/2.4 mL (20.8 mg/mL) 0002-6523-11 4 doses of 15 mg/0.6 mL 60 mg/2.4 mL (25 mg/mL) 0002-6612-11 Single-Patient-Use KwikPen (with four weekly doses) Doses per KwikPen Strength 1 pack Single-Patient-Use KwikPen NDC 4 doses of 2.5 mg 10 mg/2.4 mL (4.17 mg/mL) 0002-3566-11 4 doses of 5 mg 20 mg/2.4 mL (8.33 mg/mL) 0002-3555-11 4 doses of 7.5 mg 30 mg/2.4 mL (12.5 mg/mL) 0002-3544-11 4 doses of 10 mg 40 mg/2.4 mL (16.7 mg/mL) 0002-3533-11 4 doses of 12.5 mg 50 mg/2.4 mL (20.8 mg/mL) 0002-3522-11 4 doses of 15 mg 60 mg/2.4 mL (25 mg/mL) 0002-3511-11

16.2Storage and Handling Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen. Protect ZEPBOUND from heat and light.

Store ZEPBOUND in the original carton to protect from light. ZEPBOUND Single-dose Pen and Single-dose Vial Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to a total of 21 days.

Discard single-dose pen and single-dose vial after a total of 21 days at room temperature. ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen Unopened vial or single-patient-use KwikPen: Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator.

If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days. After vial or single-patient-use KwikPen has been opened: Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)]. Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.

16.1How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4…

📦 Storage and Handling ~1 min read ▾

16.2Storage and Handling Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen. Protect ZEPBOUND from heat and light.

Store ZEPBOUND in the original carton to protect from light. ZEPBOUND Single-dose Pen and Single-dose Vial Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to a total of 21 days.

Discard single-dose pen and single-dose vial after a total of 21 days at room temperature. ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen Unopened vial or single-patient-use KwikPen: Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator.

If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days. After vial or single-patient-use KwikPen has been opened: Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)]. Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.

📋 Description ~1 min read ▾

11 DESCRIPTION ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C 225 H 348 N 48 O 68 .

Structural formula: ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL.

Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5.

Each single-patient-use KwikPen contains additional volume to allow for device priming. Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) . Risk of Thyroid C-Cell Tumors Inform patients that ZEPBOUND causes thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] .

Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.2 )] . Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions.

Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.3 )] . Acute Gallbladder Disease Inform patients of the risk of acute gallbladder disease.

Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected [see Warnings and Precautions ( 5.4 )] . Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue ZEPBOUND promptly and contact their healthcare provider if pancreatitis is suspected [see Warnings and Precautions ( 5.5 )] .

Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported with use of tirzepatide. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking ZEPBOUND and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.6 )] . Hypoglycemia Inform patients of the risk of hypoglycemia and educate patients on the signs and symptoms of hypoglycemia.

Advise patients on insulin or insulin secretagogue therapy that they may have an increased risk of hypoglycemia when using ZEPBOUND and to report signs and/or symptoms of hypoglycemia to their healthcare provider [see Warnings and Precautions ( 5.7 )] . Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus Inform patients with type 2 diabetes mellitus to contact their healthcare provider if changes in vision are experienced during treatment with ZEPBOUND [see Warnings and Precautions ( 5.8 )] .

Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that ZEPBOUND may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking ZEPBOUND [see Warnings and Precautions ( 5.9 )] . Never Share a ZEPBOUND KwikPen Between Patients Advise patients that they must never share a ZEPBOUND KwikPen with another person, even if the pen needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.10 )] .

Pregnancy Advise a pregnant patient of the potential risk to a fetus. Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with ZEPBOUND. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZEPBOUND during pregnancy [see Use in Specific Populations ( 8.1 )] .

Contraception Use of ZEP…

💬 Medication Guide ~3 min read ▾

PATIENT MEDICATION GUIDE This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2026 Medication Guide ZEPBOUND ® (ZEHP-bownd) (tirzepatide) injection, for subcutaneous use Do not share your ZEPBOUND KwikPen or needles with other people, even if the needle has been changed.

You may give other people a serious infection, or get a serious infection from them. What is the most important information I should know about ZEPBOUND? ZEPBOUND may cause serious side effects, including: Possible thyroid tumors, including cancer.

Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, ZEPBOUND and medicines that work like ZEPBOUND caused thyroid tumors, including thyroid cancer.

It is not known if ZEPBOUND will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use ZEPBOUND if you or any of your family have ever had a type of thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). What is ZEPBOUND?

ZEPBOUND is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with: obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate to severe obstructive sleep apnea (OSA) and obesity to improve their OSA. ZEPBOUND contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if ZEPBOUND is safe and effective for use in children.

Do not use ZEPBOUND if: you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN 2. you have had a serious allergic reaction to tirzepatide or any of the ingredients in ZEPBOUND. See the end of this Medication Guide for a complete list of ingredients in ZEPBOUND. See " What are the possible side effects of ZEPBOUND? " for symptoms of a serious allergic reaction.

Before using ZEPBOUND, tell your healthcare provider about all of your medical conditions, including if you: have or have had problems with your pancreas. have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food. have a history of diabetic retinopathy. are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). are pregnant or plan to become pregnant. ZEPBOUND may harm your unborn baby. Tell your healthcare provider if you become pregnant while using ZEPBOUND.

Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken ZEPBOUND during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at [email protected] or visit https://pregnancyregistry.lilly.com/zepbound.

Birth control pills by mouth may not work as well while using ZEPBOUND. If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 4 weeks after you start ZEPBOUND and for 4 weeks after each increase in your dose of ZEPBOUND. Talk to your healthcare provider about birth control methods that may be right for you while using ZEPBOUND. are breastfeeding or plan to breastfeed.

ZEPBOUND may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using ZEPBOUND. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ZEPBOUND may affect the way some medicines work, and some medici…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.