by Novo Nordisk Pharmaceutical Industries, LP · 30 TABLET in 1 BOTTLE, PLASTIC
This is a package of 30 tablets of Wegovy semaglutide 9 mg Tablet from Novo Nordisk Pharmaceutical Industries, LP, marketed since Jan 2026 and currently FDA-listed; retail pharmacies pay about $43.47 per tablet (NADAC). It is this product's only package size.
NDC 00169-4409-31
🏷️ FDA NDC (as labeled)0169-4409-31billing pads the labeler segment with a zero
🗂️ 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
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 0169-4409-31 alone.
Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0169 labeler · 4409 product · 31 package
Package marketed since
Jan 6, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 0169440931 6
Medicaid fills, this package
12 prescriptions in the last four reported quarters
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)0169-4409-31
Product NDC0169-4409
11-digit billing NDC00169440931
NCPDP billing unitEA — each (per item)
Application #NDA218316
SPL Set IDf7b108b9-f276-4e32-84e7-e828ba145da5
Established class (EPC)GLP-1 Receptor Agonist
Mechanism of actionGlucagon-like Peptide-1 (GLP-1) Agonists
Chemical classGlucagon-Like Peptide 1
DEA scheduleNon-controlled
Marketing categoryNDA
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2026-01-06
RouteORAL
Dosage formTABLET
SubstanceSEMAGLUTIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No088491
GCN58621
HICL code044675
Ingredient (HICL)Semaglutide
HIC1 codeJ
Therapeutic class — broad (HIC1)Autonomic Nervous System
HIC2 codeJ8
Therapeutic class — intermediate (HIC2)Anti-Obesity - Anorexics
HIC3 codeJ8E
Therapeutic class — specific (HIC3)Anti-Obesity Glucagon-Like Peptide-1 Recep Agonist
AHFS code28:20.08.92
AHFS classAnorexigenic Agents, Miscellaneous
FDB label nameWEGOVY 9 MG TABLET
FDB brand nameWegovy
Legend statusF — Federal legend — prescription drug or device
Quick answers
GSN (GCN sequence number):088491
GCN:58621
HICL (First Databank):044675
AHFS class code:28:20.08.92
Why two NDCs?
The FDA registers this code as 0169-4409-31 — 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 → 00169-4409-31. 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.
Label name WEGOVY 9 MG TABLETIngredient 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...
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...
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.
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
$43.465
$1,303.96 / 30 tablets
Medicaid paysCMS SDUD · 12 mo
$44.68
$1,340.49 / 30 tablets
Medicare drug plans payPart D · Q2 2026
$45.64
$1,369.11 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 1% over the last 6 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.
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.
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, 2025RLDRS⏳ ~12.3 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.
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.
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for WEGOVY 9 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.
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, 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.
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 applicationNDA218316 (NDA)
Labeler code00169
First marketedJan 2026
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.
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.
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 this package alone, 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
12
Units reimbursed last 4 qtrs
360
Gross reimbursed last 4 qtrs
$16.1K
Avg / prescription
$1,340.49
Avg / unit
$44.6831
Latest quarter Q1 2026
12Rx
Medicaid pays / ea
$44.6831
gross reimbursed
vs
NADAC / ea
$43.4652
acquisition cost
=
Spread
+$1.2179
+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 · 12 Rx
State Medicaid map
Units reimbursed · per 100k residents
3.33.3
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1North Carolina3.3 /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.
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
Serious outcomes
Hospitalization14,338
Life-threatening1,355
Death1,270
Reports over time (by year) — tap or hover for the count & year
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.
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.