🆔 Identity & classification

FDA NDC (as labeled) 0169-4404-31

Product NDC 0169-4404

11-digit billing NDC 00169440431

NCPDP billing unit EA — each (per item)

Application # NDA218316

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 2026-01-06

Route ORAL

Dosage form TABLET

Substance SEMAGLUTIDE

GCN Seq No 088490

GCN 58619

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 4 MG TABLET

FDB brand name Wegovy

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 0169-4404-31 — 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 → 00169-4404-31. 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

LabelerNovo Nordisk Pharmaceutical Industries, LP

Application holderNOVO NORDISK INC

FDA applicationNDA218316 (NDA)

Labeler code00169

First marketedJan 2026

Product typeHuman Prescription Drug

Portfolio31 products on file

🔎 All NDCs from Novo Nordisk Pharmaceutical Industries,...

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

Label name WEGOVY 4 MG TABLET Ingredient Semaglutide

📖 What it is MedlinePlus · NLM

Semaglutide is used for the following: to control blood sugar levels in certain people with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally). to reduce the risk of a heart attack, stroke, or death in people with heart and blood vessel disease who have type 2 diabetes or who are obese or overweight. to assist with weight loss and maintenance in certain people who are obese or overweight and have at least one weight-related medical problem. Semaglutide is in a class of medications called incretin mimetics. It works by helpin...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

They both contain semaglutide, yes, but they're approved for different things. Ozempic is approved to treat type 2 diabetes and reduce heart risk in people with type 2 diabetes. We...
What's the difference between Ozempic and Wegovy — aren't they the same drug?
Nausea is genuinely the most common side effect — a lot of people experience it, especially in the first few weeks or when the dose gets bumped up. The good news is it usually ease...
I feel nauseous all the time since starting this. Is that normal, and will it go away?

📖 Read our full Semaglutide guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Semaglutide — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Semaglutide (256 interactions) — ranked by severity →

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.

COENZYME Q10 Insignificant Depletion

🧪 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.

💊 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.

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

UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 1YTW0422YU
A chemical compound that helps enhance absorption of medications in the intestines. It works as a permeation enhancer, allowing drugs to pass more easily through the gut lining into the bloodstream.

2 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$43.481	$1,304.44 / 30 tablets
Medicaid paysCMS SDUD · 12 mo	$44.67	$1,339.97 / 30 tablets
Medicare drug plans payPart D · Q2 2026	$45.64	$1,369.17 / 30 tablets

NADAC price history (per ea) — tap or hover for the price & month

▲ Up 1% over the last 5 months.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ozempic 4 mg 00169-1704-30	Novo	30 tablets	$33.151	—	Availability likely	save 24%
Wegovy 4 mgthis 00169-4404-31	Novo	30 tablets	$43.481	—	Availability likely	—

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

🏛️

2025

First FDA approval

Dec 2025

📍

2026

Currently FDA-listed

1 year 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 Feb 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Dec 22, 2025 RLD RS ⏳ ~12.4 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 12396953 — method of use (U-4387)

US 12239739 — method of use (U-4388)

US 11833248 — method of use (U-4387)

US 10278923 — method of use (U-4389)

US 9278123 — method of use (U-4389)

US 11033499 — method of use (U-4496)

US 8129343 — drug substance

US 11382957 — drug product

US 8536122 — drug substance

US 8129343 — drug substance

US 8536122 — drug substance

US 11382957 — drug product

US 8129343 — drug substance

US 8536122 — drug substance

Exclusivity I-935

Exclusivity NP

Exclusivity I-935

Exclusivity NP

Exclusivity I-935

Exclusivity NP

Exclusivity I-935

Exclusivity NP

2025 2027 2029 2031 2033 2035 2037 2039

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 (34)

Patent	Type	Use code	Expires
US 12396953 ↗	Method of use	U-4387	Feb 1, 2039
US 12396953 ↗	Method of use	U-4387	Feb 1, 2039
US 12396953 ↗	Method of use	U-4387	Feb 1, 2039
US 12396953 ↗	Method of use	U-4387	Feb 1, 2039
US 12239739 ↗	Method of use	U-4388	May 2, 2034
US 12239739 ↗	Method of use	U-4388	May 2, 2034
US 12239739 ↗	Method of use	U-4388	May 2, 2034
US 12239739 ↗	Method of use	U-4388	May 2, 2034
US 11833248 ↗	Method of use	U-4387	Feb 1, 2039
US 11833248 ↗	Method of use	U-4387	Feb 1, 2039
US 11833248 ↗	Method of use	U-4387	Feb 1, 2039
US 11833248 ↗	Method of use	U-4387	Feb 1, 2039
US 10278923 ↗	Method of use	U-4389	May 2, 2034
US 10278923 ↗	Method of use	U-4389	May 2, 2034
US 10278923 ↗	Method of use	U-4389	May 2, 2034
US 10278923 ↗	Method of use	U-4389	May 2, 2034
US 9278123 ↗	Method of use	U-4389	Dec 16, 2031
US 9278123 ↗	Method of use	U-4389	Dec 16, 2031
US 11033499 ↗	Method of use	U-4496	Jun 19, 2033
US 11033499 ↗	Method of use	U-4496	Jun 19, 2033
US 11033499 ↗	Method of use	U-4496	Jun 19, 2033
US 11033499 ↗	Method of use	U-4496	Jun 19, 2033
US 8129343 ↗	Drug substance	—	Dec 5, 2031
US 11382957 ↗	Drug product	—	Dec 16, 2031
US 8536122 ↗	Drug substance	—	Mar 20, 2026
US 8536122 ↗	Drug substance	—	Mar 20, 2026
US 8129343 ↗	Drug substance	—	Dec 5, 2031
US 8129343 ↗	Drug substance	—	Dec 5, 2031
US 8536122 ↗	Drug substance	—	Mar 20, 2026
US 11382957 ↗	Drug product	—	Dec 16, 2031
US 11382957 ↗	Drug product	—	Dec 16, 2031
US 11382957 ↗	Drug product	—	Dec 16, 2031
US 8129343 ↗	Drug substance	—	Dec 5, 2031
US 8536122 ↗	Drug substance	—	Mar 20, 2026

FDA exclusivity

Code	What it grants	Expires
I-935	New indication (3-year)	Mar 8, 2027
NP	New Product	Dec 22, 2028
I-935	New indication (3-year)	Mar 8, 2027
NP	New Product	Dec 22, 2028
I-935	New indication (3-year)	Mar 8, 2027
NP	New Product	Dec 22, 2028
I-935	New indication (3-year)	Mar 8, 2027
NP	New Product	Dec 22, 2028

Common questions

Is there a generic version of WEGOVY 4 MG TABLET?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for WEGOVY 4 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00169-4404-31, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2026 – Q1 2026 · 1 quarter of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

174

Units reimbursed last 4 qtrs

5.2K

Gross reimbursed last 4 qtrs

$233.2K

Avg / prescription

$1,339.97

Avg / unit

$44.6656

Latest quarter Q1 2026

174Rx

Medicaid pays / ea

$44.6656

gross reimbursed

vs

NADAC / ea

$43.4814

acquisition cost

=

Spread

+$1.1842

+3% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 174 Rx

State Medicaid map

Units reimbursed · per 100k residents

11.233.5

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 North Carolina 33.5 /100k

2 Indiana 12.7 /100k

3 Utah 11.4 /100k

4 Mississippi 11.2 /100k

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00169-4404-31 You're viewing this	30 TABLET in 1 BOTTLE, PLASTIC (0169-4404-31)	2026-01-06	Active

📄 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 ↗

🔗 Related NDC lookups

🧪 All Semaglutide NDCsSame ingredient 🏭 All Novo labeler NDCsLabeler code 00169 📚 All GLP-1 Receptor Agonist NDCsDrug class 📖 Read the Semaglutide drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Anti-Obesity Glucagon-Like Peptide-1 Recep Agonist.

Orforglipron Calcium 00002-4178-31 Liraglutide 00169-2800-15

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

WEGOVY semaglutide 4 mg Tablet, 30-count

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

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

📦 Packaging — all sizes for this product

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class