FDA-filed SPL labeling · retrieved through openFDA

Tirzepatide

Tirzepatide is a prescription injectable medication used to treat type 2 diabetes, reduce excess body weight, and treat obstructive sleep apnea in adults, available as Mounjaro and Zepbound.

Brand names MounjaroZepboundMounjaro KwikPenZepbound KwikPen
Drug classes Glucose-dependent Insulinotropic Polypeptide Receptor Agonist
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveAug 28, 2026
Clinical labels in scope 8
AvailabilityRx
Earliest approval/marketing year 2022
FDA-listed product records 250
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Other forms & routes:
Tirzepatide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Tirzepatide (Mounjaro and Zepbound) is a once-weekly injectable medication that works on two hormone receptors to lower blood sugar, reduce appetite, support weight loss, and — for Mounjaro — lower the risk of serious heart events in adults with type 2 diabetes. It is generally well tolerated, though stomach-related side effects are common especially at the start. Anyone with a personal or family history of medullary thyroid carcinoma or MEN 2 syndrome should not use it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Tirzepatide caused thyroid tumors in rats, including a type called medullary thyroid carcinoma (MTC). It is not yet known whether this same risk applies to people. Because of this, both Mounjaro and Zepbound must not be used by anyone who has — or has a family member who has — a history of MTC or a rare genetic condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your doctor right away if you notice a lump or mass in your neck, have trouble swallowing or breathing, or develop a persistent hoarse voice — these could be signs of a thyroid tumor. Routine blood or ultrasound screening for thyroid cancer is not reliably useful for catching this early in people taking tirzepatide.

Read the full warning on DailyMed →

📖 Tirzepatide: Patient Information Guide

A plain-language walkthrough of Tirzepatide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Tirzepatide is the active ingredient in two brand-name products — Mounjaro and Zepbound — each approved for distinct uses.

  • Mounjaro: Improves blood sugar control in adults and children aged 10 and older with type 2 diabetes, used alongside diet and exercise
  • Mounjaro: Reduces the risk of major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes who are at high cardiovascular risk
  • Zepbound: Reduces excess body weight and maintains weight loss long-term in adults with obesity, or adults who are overweight with at least one weight-related health condition — used with a reduced-calorie diet and increased physical activity
  • Zepbound: Treats moderate to severe obstructive sleep apnea (OSA) in adults with obesity — used alongside diet and exercise
⚙️How it works

Tirzepatide binds to and activates two hormone receptors: the GIP (glucose-dependent insulinotropic polypeptide) receptor and the GLP-1 (glucagon-like peptide-1) receptor. Activating GLP-1 receptors boosts insulin release when blood sugar rises, reduces glucagon (a hormone that raises blood sugar), slows digestion, and curbs appetite. Adding GIP receptor activation appears to further support appetite and food-intake regulation. Both receptor types are also found in brain areas that control hunger, and animal studies show tirzepatide activates neurons in those regions — helping explain how it reduces body weight alongside blood sugar.

💊How it's taken

Tirzepatide is given as a once-weekly subcutaneous injection (under the skin) at any time of day, with or without food. Both Mounjaro and Zepbound are started at a low dose and gradually increased over several weeks — this step-up approach is designed to minimize stomach-related side effects. Your prescriber will determine your maintenance dose based on how well you respond and how you tolerate it.

  • Inject in the abdomen, thigh, or (by another person) the back of the upper arm; rotate the site each week
  • If you miss a dose, take it as soon as possible within 4 days (96 hours); if more than 4 days have passed, skip it and resume your normal schedule
  • You can shift the day you take your weekly dose as long as at least 3 days (72 hours) separate two consecutive doses
🤒Side effects — in detail

The most common side effects with tirzepatide involve the stomach and digestive system, and they tend to be worst early on or after a dose increase.

  • Nausea
  • Diarrhea
  • Decreased appetite
  • Vomiting
  • Constipation
  • Indigestion (dyspepsia)
  • Abdominal pain
  • Burping, gas, or bloating

Serious reactions to watch for include severe abdominal pain (possible pancreatitis), signs of low blood sugar if you also use insulin or a sulfonylurea, sudden allergic reactions (swelling, trouble breathing), and symptoms of thyroid tumors (neck lump, hoarseness, difficulty swallowing). Seek medical help right away if any of these occur.

⚠️Warnings & precautions
  • Thyroid tumor risk: Tirzepatide caused thyroid C-cell tumors in rats. Whether this applies to humans is unknown, but anyone with a personal or family history of medullary thyroid carcinoma (MTC) or MEN 2 syndrome must not use it. Watch for a neck lump, hoarseness, or trouble swallowing.
  • Pancreatitis: Serious pancreas inflammation has been reported. Persistent or severe abdominal pain — sometimes radiating to the back — is a red flag. Stop the medication and call your doctor immediately.
  • Low blood sugar (hypoglycemia): Risk increases when tirzepatide is combined with insulin or drugs like sulfonylureas. Your doctor may lower those doses when you start.
  • Kidney injury: Severe vomiting or diarrhea can cause dehydration, which can harm the kidneys. Stay hydrated and let your doctor know if GI symptoms are severe.
  • Gallbladder problems: Gallstones and gallbladder inflammation (cholecystitis) have been reported, particularly with weight loss.
  • Serious allergic reactions: Anaphylaxis and angioedema (severe swelling) have been reported. Seek emergency care right away if this occurs.
  • Aspiration risk during surgery: Because tirzepatide slows stomach emptying, there is a risk of inhaling stomach contents under general anesthesia. Tell your surgical team you are taking it.
  • Diabetic retinopathy: Patients with a history of diabetic eye disease (retinopathy) should be monitored for progression during treatment.
🔀What it interacts with

Tirzepatide can interact with several medications, mainly because it slows how fast the stomach empties — which affects how quickly your body absorbs other drugs you take by mouth.

  • Insulin and sulfonylureas (e.g., glipizide, glimepiride): Combining these with tirzepatide raises the risk of low blood sugar; your doctor may reduce their doses
  • Oral hormonal contraceptives (birth control pills): Effectiveness may be reduced; switch to a non-oral method or add a barrier method for 4 weeks after starting and after each dose increase
  • Warfarin and narrow-therapeutic-index drugs: Slower pill absorption can affect drug levels that need to stay in a precise range — monitoring is important
  • Any oral medication: All pills taken by mouth have the potential for delayed absorption, so mention all your medications to your doctor or pharmacist
  • Other tirzepatide products or GLP-1 receptor agonists: Do not combine — overlapping mechanisms increase the risk of side effects without added benefit

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • History of medullary thyroid carcinoma (MTC) or MEN 2: Tirzepatide is contraindicated — do not use it
  • Serious allergy to tirzepatide: Do not use if you have ever had anaphylaxis or angioedema from it
  • Pregnancy: Animal studies suggest a risk of fetal harm; discuss with your doctor whether the benefit outweighs the risk
  • Breastfeeding: Tirzepatide appears in breast milk in very small amounts; the effects on a nursing infant are unknown — discuss with your doctor
  • Oral contraceptives: Talk to your doctor before starting; you may need to switch to or add a non-oral method
  • History of pancreatitis, gallbladder disease, or diabetic retinopathy: Tell your doctor — closer monitoring may be needed
  • Severe gastroparesis (very slow stomach emptying): Zepbound is not recommended; discuss with your doctor
  • Children under 10: Mounjaro has not been established as safe or effective in this age group; Zepbound has not been studied in children
  • Older adults (65+): No overall differences in safety or effectiveness have been observed, but standard precautions apply
  • Kidney or liver impairment: No dose adjustment is needed, but kidney function should be monitored if severe GI side effects cause dehydration
🚑If you take too much

If too much tirzepatide is taken, the most likely issues relate to its known side effects — particularly stomach symptoms and low blood sugar if combined with other glucose-lowering medications. Because tirzepatide stays in the body for approximately 5 days, any effects from an overdose could persist for some time. Contact the Poison Help line (1-800-222-1222) or seek medical attention right away if an overdose is suspected, and follow the guidance of healthcare providers for supportive care.

📡Pharmacodynamics — effects in the body

Tirzepatide lowers fasting and after-meal blood sugar by boosting insulin release and reducing glucagon — both in a way that depends on blood sugar levels, so the effect is naturally self-limiting. It also slows how quickly food leaves the stomach (gastric emptying), which smooths out blood sugar spikes after meals and reduces calorie absorption. Beyond blood sugar, it decreases food intake and reduces body weight, and increases the body's sensitivity to insulin.

🔬Pharmacokinetics — how your body processes it

After a subcutaneous injection, tirzepatide is absorbed gradually — blood levels typically peak somewhere between 8 and 72 hours after the dose. About 80% of the injected dose reaches the bloodstream. Tirzepatide is 99% bound to albumin (a protein in the blood), which helps slow its clearance and gives it a half-life of approximately 5 to 6 days — long enough to make once-weekly dosing effective. Steady, consistent drug levels in the blood are reached after about 4 weeks of weekly dosing. The drug is broken down through normal protein metabolism and eliminated through both urine and feces as metabolites; intact tirzepatide is not found in urine or feces. Neither kidney nor liver impairment meaningfully changes how the body handles tirzepatide.

📦How to store it

Do not freeze MOUNJARO. Store MOUNJARO in the original carton to protect from light. Store MOUNJARO single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F).

📄 Written from Tirzepatide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Tirzepatide — the kind of thing our pharmacy team would talk through with you at the counter.

What's the difference between Mounjaro and Zepbound if they're the same drug?
Great question — same ingredient, different approvals. Mounjaro is FDA-approved specifically for type 2 diabetes (to improve blood sugar control and, in high-risk adults, to lower the chance of heart attack or stroke). Zepbound carries approvals for weight reduction in adults with obesity or overweight with a related health condition, and for treating moderate to severe obstructive sleep apnea in adults with obesity. Your prescriber picks the brand that matches your diagnosis.
What side effects should I actually expect when I start?
The most common ones are stomach-related — nausea, diarrhea, vomiting, constipation, and stomach pain. These tend to hit hardest in the first few weeks or after a dose increase, then often ease up. That's exactly why the dose is started low and bumped up gradually. Staying hydrated and not eating huge meals can help. If nausea or vomiting is so bad you can't keep fluids down, call your doctor — severe dehydration can affect your kidneys.
Should I worry about the thyroid cancer warning I read about?
It's worth taking seriously, but keep it in context. The thyroid tumors were seen in rats given tirzepatide — it has not been confirmed to cause this in people. That said, if you or a close family member has ever had medullary thyroid carcinoma (a specific type of thyroid cancer) or a condition called MEN 2, you should not use this medication at all. For everyone else, the key is knowing the warning signs: a lump in your neck, persistent hoarseness, trouble swallowing, or breathing changes. Tell your doctor right away if any of those come up.
I'm also on birth control pills — is that a problem?
It can be. Tirzepatide slows down how quickly your stomach empties, and that can reduce how well your oral birth control pill is absorbed — especially in the first few weeks of treatment or after a dose increase. Your doctor or pharmacist will likely advise you to switch to a non-oral contraceptive (like a patch, ring, or injection) or to add a barrier method like condoms for at least 4 weeks after starting and after each dose step-up. Non-oral hormonal contraceptives are not affected.
What if I miss a dose?
If you remember within 4 days (96 hours) of your missed dose, go ahead and take it as soon as you can, then get back on your regular weekly schedule. If more than 4 days have passed, skip that missed dose and just take your next one on the usual day. You can also shift which day of the week you inject — just make sure at least 3 days (72 hours) separate any two doses.
I'm scheduled for surgery — do I need to tell the anesthesia team I take this?
Yes — and this is important. Because tirzepatide slows how quickly your stomach empties, there is a risk that you could inhale stomach contents while under general anesthesia or deep sedation. Let your surgical team and anesthesiologist know you are taking it well before your procedure so they can take appropriate precautions. Don't assume they already know.
Is Tirzepatide available over the counter?
Tirzepatide is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Tirzepatide first available?
Tirzepatide has been available in the United States since at least 2022, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tirzepatide?
Tirzepatide is supplied by 42 manufacturers listed in the FDA NDC Directory, including Eli Lilly and Company, Hybio Pharmaceutical Co., Ltd., Resilience US, LLC.

💬 Answers drafted from Tirzepatide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Tirzepatide comes

Tirzepatide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Under the skin
Brands Mounjaro Zepbound
How this form is used
What it may be used for
  • Mounjaro is used to improve blood sugar control in adults and children aged 10 and older with type 2 diabetes, as an addition to diet and exercise
  • Mounjaro is used to reduce the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes at high cardiovascular risk
  • Zepbound is used to reduce excess body weight and maintain that weight reduction long-term in adults with obesity or overweight with a related health condition, along with diet and exercise
  • Zepbound is used to treat moderate to severe obstructive sleep apnea in adults with obesity, along with diet and exercise
Important instructions
  • Both Mounjaro and Zepbound are injected subcutaneously (under the skin) once weekly, at any time of day, with or without food
  • Inject in the abdomen, thigh, or — if another person is administering — the back of the upper arm; rotate injection sites with each dose
  • Mounjaro and Zepbound KwikPen products are not recommended for self-administration by those who are visually impaired; Mounjaro KwikPen is also not recommended for self-administration by pediatric patients
  • If using Mounjaro alongside insulin, give them as separate injections — never mixed together — though they may be given in the same body region
Available strengths 18 strengths
Show 12 more strengths Show fewer strengths
168 FDA-listed product records

📊 Tirzepatide across the U.S. market

How Tirzepatide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
42
Manufacturers
4
Brand names
250
FDA-listed product records
2022
First marketed

Also listed with the FDA, not a patient dose form: Powder (82) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Eli Lilly and Company49%
Hybio Pharmaceutical Co., Ltd.8%
Resilience US, LLC7%
Eli Lilly Italia SPA7%
Aurisco Pharmaceutical Co.,Ltd4%
BSP Pharmaceuticals SpA2%
Other makers23%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Tirzepatide is used

A general measure of how commonly Tirzepatide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tirzepatide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,083,095
Medicaid prescriptions filled (Q1–Q4 2025)
$3.26B gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tirzepatide prescribed? Of the 1,596 medications we measure, Tirzepatide ranks #70 by Medicaid prescriptions — more than 96% of them.

Where Tirzepatide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Tirzepatide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.5 mL / 10 mg/mL auto-injector is the most-dispensed Tirzepatide product — about 25% of these Medicaid prescriptions.

0.5 ML tirzepatide 10 MG/ML Auto-Injector Most dispensed

765,721 Medicaid prescriptions (Q1–Q4 2025) 25% of Tirzepatide prescriptions shown $807.7M gross reimbursement (before rebates) ≈ $1,055 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2601743

0.5 ML tirzepatide 5 MG/ML Auto-Injector

630,866 Medicaid prescriptions (Q1–Q4 2025) 20% of Tirzepatide prescriptions shown $663.4M gross reimbursement (before rebates) ≈ $1,052 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2601761

0.5 ML tirzepatide 15 MG/ML Auto-Injector

582,692 Medicaid prescriptions (Q1–Q4 2025) 19% of Tirzepatide prescriptions shown $616.1M gross reimbursement (before rebates) ≈ $1,057 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2601784

0.5 ML tirzepatide 20 MG/ML Auto-Injector

467,010 Medicaid prescriptions (Q1–Q4 2025) 15% of Tirzepatide prescriptions shown $494.9M gross reimbursement (before rebates) ≈ $1,060 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2601767

0.5 ML tirzepatide 30 MG/ML Auto-Injector

364,205 Medicaid prescriptions (Q1–Q4 2025) 12% of Tirzepatide prescriptions shown $391.2M gross reimbursement (before rebates) ≈ $1,074 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2601755

0.5 ML tirzepatide 25 MG/ML Auto-Injector

272,601 Medicaid prescriptions (Q1–Q4 2025) 9% of Tirzepatide prescriptions shown $289.4M gross reimbursement (before rebates) ≈ $1,062 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2601773

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tirzepatide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 26 listed Tirzepatide NDCs with Medicaid activity.

🔍 Compare Tirzepatide products

A representative set of FDA-listed product records for Tirzepatide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 250 products — FDA National Drug Code Directory. See every product, package size and price: browse all 250 Tirzepatide NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tirzepatide RxCUI 2601723 4 dose forms · 24 strengths

Look up RxCUI 2601723 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Mounjaro Zepbound Mounjaro KwikPen Zepbound KwikPen

🏭 Manufacturers & labelers

Eli Lilly and Company 121 Hybio Pharmaceutical Co., Ltd. 19 Resilience US, LLC 18 Eli Lilly Italia SPA 18 Aurisco Pharmaceutical Co.,Ltd 10 BSP Pharmaceuticals SpA 6 A-S Medication Solutions 6 Zhejiang Kingland Pharmaceutical Company Limited 5 Sinopep-Allsino Biopharmaceutical Co., Ltd. 5 Shanghai SynTheAll Pharmaceutical Co., Ltd. 5 Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) 3 Zhejiang Tasln Biopharma Co., Ltd. 2 Medisca Inc. 2 Chengdu Shengnuo Biopharm Co., Ltd. 2 Shanghai Patience Biotech Co., Ltd. 1 Shenzhen Alvantis Pharma Co., Ltd. 1 Sichuan Jisheng Biopharmaceutical Co Ltd 1 Qingdao Biopeptek Co., Ltd. 1 Pharma Source Direct, Inc. 1 Nomida LLC 1 Nanjing Hanxin Pharmaceutical Technology Co., Ltd. 1 Nanjing Chengong Pharmaceutical Co., Ltd. 1 Suzhou Lixin Pharmaceutical Co., Ltd. 1 Thaeta Scientific LLC 1

…and 16 more on the FDA NDC directory.

RxNorm drug class

Tirzepatide belongs to the GLP-1 Receptor Agonist class.

Pharmacologic class GLP-1 Receptor Agonist, Glucose-dependent Insulinotropic Polypeptide Receptor Agonist
Drug family (ATC) Other blood glucose lowering drugs, excl. insulins
How it works G-Protein-linked Receptor Interactions, Glucagon-like Peptide-1 (GLP-1) Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 28, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tirzepatide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tirzepatide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
8
NDC products indexed
250
Distinct labelers/manufacturers represented
42
Linked representative label
Eli Lilly and Company
Linked label effective
Aug 28, 2026
Composite sections available
25
Linked SPL Set ID
487cd7e7-434c-4925-99fa-aa80b1cc776b
Linked SPL Document ID
a5dba1a3-f7f7-4b8d-b9f1-a09dcdc1b2fc
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Eli Lilly and Company is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.