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WEGOVY semaglutide .25 mg/.5mL Injection, Solution, 4 syringes — NDC 00169-4525-94 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

WEGOVY semaglutide .25 mg/.5mL Injection, Solution, 4 syringes — NDC 0169-4525-94 (Billing 00169-4525-94)

by Novo Nordisk Pharmaceutical Industries, LP · 4 SYRINGE, PLASTIC in 1 CARTON / .5 mL in 1 SYRINGE, PLASTIC

This is a package of 4 syringes of WEGOVY semaglutide .25 mg/.5mL Injection, Solution from Novo Nordisk Pharmaceutical Industries, LP, marketed since Jun 2021 and currently FDA-listed.

NDC 00169-4525-94
🏷️ FDA NDC (as labeled) 0169-4525-94 billing pads the labeler segment with a zero
This package
Contains4 syringes Pack sizes2 compare ↓
Also priced by: Part D plans $664.52/unit — full pricing hub ↓
Product page 00169-4525-14 Also comes in: 4 syringes 0169-4525-14
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0169-4525-94 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0169 labeler · 4525 product · 94 package
Package marketed since
Jun 5, 2021
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0169452594 8
FDA record last changed
Oct 8, 2026
🚨
Active recall for this product.
Class II · Dec 19, 2025 — Presence of Particulate Matter: Hair was found in a prefilled syringe (Novo Nordisk Inc.) · FDA recall D-0244-2026
Lots / codes: Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026 · reported Jan 7, 2026
Class II · Dec 19, 2025 — Presence of Particulate Matter: Hair was found in a prefilled syringe (Novo Nordisk Inc.) · FDA recall D-0245-2026
Lots / codes: Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027 · reported Jan 7, 2026
Class II · Apr 9, 2025 — Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released. (Cardinal Health Inc.) · FDA recall D-0393-2025
Lots / codes: Lot PZFDE06, Exp 08/31/2025 · reported May 7, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0169-4525-94
Product NDC 0169-4525
11-digit billing NDC 00169452594
Application # NDA215256
SPL Set ID f7b108b9-f276-4e32-84e7-e828ba145da5
Established class (EPC) GLP-1 Receptor Agonist
Mechanism of action Glucagon-like Peptide-1 (GLP-1) Agonists
Chemical class Glucagon-Like Peptide 1
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-05
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance SEMAGLUTIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 082355
GCN 49748
HICL code 044675
Ingredient (HICL) Semaglutide
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J8
Therapeutic class — intermediate (HIC2) Anti-Obesity - Anorexics
HIC3 code J8E
Therapeutic class — specific (HIC3) Anti-Obesity Glucagon-Like Peptide-1 Recep Agonist
AHFS code 28:20.08.92
AHFS class Anorexigenic Agents, Miscellaneous
FDB label name WEGOVY 0.25 MG/0.5 ML PEN
FDB brand name Wegovy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082355
  • GCN: 49748
  • HICL (First Databank): 044675
  • AHFS class code: 28:20.08.92
Why two NDCs? The FDA registers this code as 0169-4525-94 — 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 → 00169-4525-94. 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.

Clinical

Label name WEGOVY 0.25 MG/0.5 ML PEN Ingredient Semaglutide
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Wegovy is used for weight management and to lower heart risks in adults with heart disease plus obesity or overweight. Wegovy injection is also used for...
  • Wegovy injection and Ozempic are weekly shots under the skin, any time of day, with or without food. Wegovy tablets are taken once daily on an empty stomach with plain water, then...
  • Nausea, diarrhea, vomiting, constipation, and stomach pain are the most common, especially early on or after a dose increase. Headache and tiredness are also common. Call your doct...
  • Call for severe stomach pain that won't go away, swelling of the face or throat, trouble breathing, a lump in your neck, trouble swallowing, or hoarseness that persists. Also call...
📖 Read our full Semaglutide guide →
1
Nutrient depletion considerations

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

🧪 Full Semaglutide 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.

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 $664.52 $1,329.04 / 2 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00169-4525-14 0169-4525-14 Main listing 4 SYRINGE, PLASTIC in 1 CARTON / .5 mL in 1 SYRINGE, PLASTIC $653.29 / mL $1,306.59 2021-06-05 — Active
00169-4525-94 You're viewing this 4 SYRINGE, PLASTIC in 1 CARTON / .5 mL in 1 SYRINGE, PLASTIC Sample — — 2021-06-05 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 4 syringes — 4 syringe, plastic in 1 carton / .5 ml in 1 syringe, plastic.
How does this package differ from NDC 00169-4525-14?
Both are WEGOVY semaglutide .25 mg/.5mL Injection, Solution — the drug itself is identical. This page's package is the 4 syringes one, while NDC 00169-4525-14 is the 4 syringes package.
What NDC number is used to bill for this package of WEGOVY semaglutide .25 mg/.5mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Wegovy .25 mg/.5mLthis 00169-4525-94 Novo 4 syringes — — FDA listed —
Wegovy .25 mg/.5mL 50090-5824-00 A-S 4 syringes — — 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

🏛️
2021
First FDA approval
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2041
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 Feb 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 4, 2021 RLD RS ⏳ ~14.4 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 12551536 — method of use (U-4418)
US 12551536 — method of use (U-4418)
US 12214017 — method of use (U-4418)
US 12029779 — method of use (U-4418)
US 11752198 — method of use (U-4418)
US 11318191 — method of use (U-4418)
US 10888605 — method of use (U-4418)
US 9764003 — method of use (U-4418)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 10888605 — method of use (U-3162)
US 9764003 — method of use (U-3161)
US 9764003 — method of use (U-3161)
US 10888605 — method of use (U-3162)
US 9764003 — method of use (U-3161)
US 10888605 — method of use (U-3162)
US 10888605 — method of use (U-3162)
US 9764003 — method of use (U-3161)
US 9764003 — method of use (U-3161)
US 10888605 — method of use (U-3162)
US 12029779 — method of use (U-3162)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-4443)
US 11318191 — method of use (U-4560)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-4443)
US 11318191 — method of use (U-4560)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-4443)
US 11318191 — method of use (U-4560)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-4443)
US 11318191 — method of use (U-4560)
US 11318191 — method of use (U-3162)
US 11318191 — method of use (U-4443)
US 11318191 — method of use (U-4560)
US 12551536 — method of use (U-4418)
US 12029779 — method of use (U-3162)
US 11478533 — method of use (U-3861)
US 9764003 — method of use (U-3161)
US 12569543 — method of use (U-4443)
US 12569543 — method of use (U-4443)
US 12569543 — method of use (U-4443)
US 12569543 — method of use (U-4443)
US 12569543 — method of use (U-4443)
US 12551536 — method of use (U-4418)
US 12551536 — method of use (U-4418)
US 12551536 — method of use (U-4418)
US 12551536 — method of use (U-4418)
US 12551536 — method of use (U-4418)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 12214017 — method of use (U-3162)
US 12029779 — method of use (U-3162)
US 12029779 — method of use (U-3162)
US 12029779 — method of use (U-3162)
US 12029779 — method of use (U-3162)
US 12029779 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11752198 — method of use (U-3162)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 11478533 — method of use (U-3861)
US 10888605 — method of use (U-3162)
US 10888605 — method of use (U-3162)
US 10888605 — method of use (U-3162)
US 10888605 — method of use (U-3162)
US 10888605 — method of use (U-3162)
US 9764003 — method of use (U-3161)
US 9764003 — method of use (U-3161)
US 9764003 — method of use (U-3161)
US 9764003 — method of use (U-3161)
US 9764003 — method of use (U-3161)
US 8536122 — drug substance
US 8129343 — drug substance
US 8536122 — drug substance
US 8129343 — drug substance
US 8129343 — drug substance
US 8129343 — drug substance
US 8129343 — drug substance
US 8129343 — drug substance
US 8536122 — drug substance
US 8129343 — drug substance
US 8536122 — drug substance
US 8129343 — drug substance
US 8129343 — drug substance
US 8129343 — drug substance
US 8536122 — drug substance
US 8129343 — drug substance
US 8129343 — drug substance
Exclusivity I-935
Exclusivity I-973
Exclusivity I-935
Exclusivity I-973
Exclusivity I-935
Exclusivity I-973
Exclusivity D-190
Exclusivity I-935
Exclusivity I-973
Exclusivity I-935
Exclusivity I-973
Exclusivity NS
Exclusivity I-935
Exclusivity I-973
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (115)
PatentTypeUse codeExpires
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12214017 ↗ Method of use U-4418 Aug 24, 2038
US 12029779 ↗ Method of use U-4418 Oct 10, 2038
US 11752198 ↗ Method of use U-4418 Aug 24, 2038
US 11318191 ↗ Method of use U-4418 Feb 17, 2041
US 10888605 ↗ Method of use U-4418 Aug 24, 2038
US 9764003 ↗ Method of use U-4418 Jun 21, 2033
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 12029779 ↗ Method of use U-3162 Oct 10, 2038
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-4443 Feb 17, 2041
US 11318191 ↗ Method of use U-4560 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-4443 Feb 17, 2041
US 11318191 ↗ Method of use U-4560 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-4443 Feb 17, 2041
US 11318191 ↗ Method of use U-4560 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-4443 Feb 17, 2041
US 11318191 ↗ Method of use U-4560 Feb 17, 2041
US 11318191 ↗ Method of use U-3162 Feb 17, 2041
US 11318191 ↗ Method of use U-4443 Feb 17, 2041
US 11318191 ↗ Method of use U-4560 Feb 17, 2041
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12029779 ↗ Method of use U-3162 Oct 10, 2038
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 12569543 ↗ Method of use U-4443 Apr 28, 2037
US 12569543 ↗ Method of use U-4443 Apr 28, 2037
US 12569543 ↗ Method of use U-4443 Apr 28, 2037
US 12569543 ↗ Method of use U-4443 Apr 28, 2037
US 12569543 ↗ Method of use U-4443 Apr 28, 2037
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12551536 ↗ Method of use U-4418 Oct 10, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12214017 ↗ Method of use U-3162 Aug 24, 2038
US 12029779 ↗ Method of use U-3162 Oct 10, 2038
US 12029779 ↗ Method of use U-3162 Oct 10, 2038
US 12029779 ↗ Method of use U-3162 Oct 10, 2038
US 12029779 ↗ Method of use U-3162 Oct 10, 2038
US 12029779 ↗ Method of use U-3162 Oct 10, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11752198 ↗ Method of use U-3162 Aug 24, 2038
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 11478533 ↗ Method of use U-3861 May 13, 2040
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 10888605 ↗ Method of use U-3162 Aug 24, 2038
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 9764003 ↗ Method of use U-3161 Jun 21, 2033
US 8536122 ↗ Drug substance — Mar 20, 2026
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8536122 ↗ Drug substance — Mar 20, 2026
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8536122 ↗ Drug substance — Mar 20, 2026
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8536122 ↗ Drug substance — Mar 20, 2026
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8536122 ↗ Drug substance — Mar 20, 2026
US 8129343 ↗ Drug substance — Dec 5, 2031
US 8129343 ↗ Drug substance — Dec 5, 2031
FDA exclusivity
CodeWhat it grantsExpires
I-935New indication (3-year)Mar 8, 2027
I-973New indication (3-year)Aug 15, 2028
I-935New indication (3-year)Mar 8, 2027
I-973New indication (3-year)Aug 15, 2028
I-935New indication (3-year)Mar 8, 2027
I-973New indication (3-year)Aug 15, 2028
D-190Other change requiring clinical data (3-year)Jul 21, 2026
I-935New indication (3-year)Mar 8, 2027
I-973New indication (3-year)Aug 15, 2028
I-935New indication (3-year)Mar 8, 2027
I-973New indication (3-year)Aug 15, 2028
NSNew StrengthMar 19, 2029
I-935New indication (3-year)Mar 8, 2027
I-973New indication (3-year)Aug 15, 2028
Common questions
Is there a generic version of WEGOVY 0.25 MG/0.5 ML PEN?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for WEGOVY 0.25 MG/0.5 ML PEN. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2041 — 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.

What it looks like

Color White
ShapeOval
Imprint25;novo
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Semaglutide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • 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.

3 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.

Manufacturer & labeler

LabelerNovo Nordisk Pharmaceutical Industries, LP
Application holderNOVO NORDISK INC
FDA applicationNDA215256 (NDA)
Labeler code00169
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio39 products on file

More NDCs from Novo Nordisk Pharmaceutical Industries, LP labeler code 00169

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.

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
4 syringes00169-4525-14 328,581 Rx · $425,879,065
4 syringes this page00169-4525-94 No Medicaid data
Drug total (last 4 qtrs): 328,581 Rx · 656,378 units · $425,879,065 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Wegovy — 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 Wegovy. 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
$297.5M
Claims incl. refills
205.6K
Beneficiaries
88.8K
Spend / beneficiary
$3,352.12
Spend / claim
$1,446.68
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Semaglutide — the ingredient across all brands.

Top reported reactions

Nausea10,674
Vomiting6,964
Diarrhoea6,462
Decreased Appetite4,905
Constipation4,724
Weight Decreased4,487
Impaired Gastric Emptying3,558

Reporter sex

0 reports

Serious outcomes

Hospitalization14,338
Life-threatening1,355
Death1,270
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 20,013 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Novo Nordisk Pharmaceutical Industries, LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 4 syringes (00169-4525-14). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Novo Nordisk Pharmaceutical Industries, LP 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.
← 00169-4524-14 · Novo 00169-4572-14 · Novo →
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.