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OZEMPIC oral semaglutide 9 mg Tablet, 30-count — NDC 00169-1709-30 package photo

OZEMPIC oral semaglutide 9 mg Tablet, 30-count

by Novo Nordisk Pharmaceutical Industries, LP · 30 TABLET in 1 BOTTLE, PLASTIC (0169-1709-30)
NDC 00169-1709-30
🏷️ FDA NDC (as labeled) 0169-1709-30 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 0169-1709-30
Product NDC 0169-1709
11-digit billing NDC 00169170930
NCPDP billing unit EA — each (per item)
RxCUI 2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549,
UNII 53AXN4NNHX
Application # NDA213051
SPL Set ID 27f15fac-7d98-4114-a2ec-92494a91da98
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 2026-04-27
Route ORAL
Dosage form TABLET
Substance SEMAGLUTIDE
GCN Seq No 087190
GCN 57038
HICL code 044675
Ingredient (HICL) Semaglutide
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4I
Therapeutic class — specific (HIC3) Antihypergly,Incretin Mimetic(Glp-1 Recep.agonist)
AHFS code 28:20.08.92
AHFS class Anorexigenic Agents, Miscellaneous
FDB label name OZEMPIC 9 MG TABLET
FDB brand name Ozempic
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0169-1709-30 — 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 → 00169-1709-30. 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.

🏷️ RxNorm drug class

This medicine belongs to the GLP-1 Receptor Agonist class.

Pharmacologic class GLP-1 Receptor Agonist
Drug family (ATC) Glucagon-like peptide-1 (GLP-1) analogues
How it works Glucagon-like Peptide-1 (GLP-1) Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNovo Nordisk Pharmaceutical Industries, LP
Application holderNOVO NORDISK INC
FDA applicationNDA213051 (NDA)
Labeler code00169
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio31 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OZEMPIC 9 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeRound
Imprint9;on;one;side;and;novo;on;other;side
Size7 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $33.213 $996.38 / 30 tablets
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 · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Aug 2026 $33.213 $33.213
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ozempic 9 mgthis 00169-1709-30 Novo 30 tablets $33.213 — Availability likely —
Wegovy 9 mg 00169-4409-31 Novo 30 tablets $43.453 — Availability likely +31%
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

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

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 9, 2024 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 8536122 — drug substance (U-2628)
US 9278123 — method of use (U-2628)
US 8129343 — drug substance (U-2628)
US 8536122 — drug substance (U-2628)
US 9278123 — method of use (U-2628)
US 8129343 — drug substance (U-2628)
US 9278123 — method of use (U-2628)
US 8129343 — drug substance (U-2628)
US 8536122 — drug substance (U-2628)
US 10278923 — method of use (U-2628)
US 10278923 — method of use (U-2628)
US 10278923 — method of use (U-2628)
US 12514822 — method of use (U-2628)
US 12514822 — method of use (U-2628)
US 12514822 — method of use (U-2628)
US 12514822 — method of use (U-2628)
US 12514822 — method of use (U-2628)
US 12514822 — method of use (U-2628)
US 12239739 — drug substance (U-2628)
US 12239739 — drug substance (U-2628)
US 12239739 — drug substance (U-2628)
US 12239739 — drug substance (U-2628)
US 12239739 — drug substance (U-2628)
US 12239739 — drug substance (U-2628)
US 8536122 — drug substance (U-2628)
US 8536122 — drug substance (U-2628)
US 8536122 — drug substance (U-2628)
US 8129343 — drug substance (U-2628)
US 8129343 — drug substance (U-2628)
US 8129343 — drug substance (U-2628)
US 11833248 — method of use (U-2628)
US 11833248 — method of use (U-2628)
US 11833248 — method of use (U-2628)
US 12396953 — method of use (U-2628)
US 12396953 — method of use (U-2628)
US 12396953 — method of use (U-2628)
US 10278923 — drug substance (U-2628)
US 10278923 — drug substance (U-2628)
US 10278923 — drug substance (U-2628)
US 9278123 — drug substance (U-2628)
US 11033499 — method of use (U-2628)
US 11033499 — method of use (U-2628)
US 11033499 — method of use (U-2628)
US 11033499 — method of use (U-2628)
US 11033499 — method of use (U-2628)
US 11033499 — method of use (U-2628)
US 10933120 — drug product
US 11759501 — drug product
US 11382957 — drug substance
US 10960052 — drug product
US 11759502 — drug product
US 11759503 — drug product
US 11759503 — drug product
US 11759503 — drug product
US 10933120 — drug product
US 10960052 — drug product
US 10086047 — drug product
US 10960052 — drug product
US 11382957 — drug product
US 12594326 — drug product
US 10933120 — drug product
US 12594326 — drug product
US 11759502 — drug product
US 11382957 — drug product
US 11382957 — drug substance
US 10086047 — drug product
US 11382957 — drug product
US 11759501 — drug product
US 11382957 — drug substance
US 11759501 — drug product
US 11759502 — drug product
US 12594326 — drug product
US 10086047 — drug product
Exclusivity I-976
Exclusivity I-976
Exclusivity I-976
Exclusivity I-976
Exclusivity I-976
Exclusivity I-976
2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

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

Listed patents (73)
PatentTypeUse codeExpires
US 8536122 ↗ Drug substance U-2628 Mar 20, 2026
US 9278123 ↗ Method of use U-2628 Dec 16, 2031
US 8129343 ↗ Drug substance U-2628 Dec 5, 2031
US 8536122 ↗ Drug substance U-2628 Mar 20, 2026
US 9278123 ↗ Method of use U-2628 Dec 16, 2031
US 8129343 ↗ Drug substance U-2628 Dec 5, 2031
US 9278123 ↗ Method of use U-2628 Dec 16, 2031
US 8129343 ↗ Drug substance U-2628 Dec 5, 2031
US 8536122 ↗ Drug substance U-2628 Mar 20, 2026
US 10278923 ↗ Method of use U-2628 May 2, 2034
US 10278923 ↗ Method of use U-2628 May 2, 2034
US 10278923 ↗ Method of use U-2628 May 2, 2034
US 12514822 ↗ Method of use U-2628 May 2, 2034
US 12514822 ↗ Method of use U-2628 May 2, 2034
US 12514822 ↗ Method of use U-2628 May 2, 2034
US 12514822 ↗ Method of use U-2628 May 2, 2034
US 12514822 ↗ Method of use U-2628 May 2, 2034
US 12514822 ↗ Method of use U-2628 May 2, 2034
US 12239739 ↗ Drug substance U-2628 May 2, 2034
US 12239739 ↗ Drug substance U-2628 May 2, 2034
US 12239739 ↗ Drug substance U-2628 May 2, 2034
US 12239739 ↗ Drug substance U-2628 May 2, 2034
US 12239739 ↗ Drug substance U-2628 May 2, 2034
US 12239739 ↗ Drug substance U-2628 May 2, 2034
US 8536122 ↗ Drug substance U-2628 Mar 20, 2026
US 8536122 ↗ Drug substance U-2628 Mar 20, 2026
US 8536122 ↗ Drug substance U-2628 Mar 20, 2026
US 8129343 ↗ Drug substance U-2628 Dec 5, 2031
US 8129343 ↗ Drug substance U-2628 Dec 5, 2031
US 8129343 ↗ Drug substance U-2628 Dec 5, 2031
US 11833248 ↗ Method of use U-2628 Feb 1, 2039
US 11833248 ↗ Method of use U-2628 Feb 1, 2039
US 11833248 ↗ Method of use U-2628 Feb 1, 2039
US 12396953 ↗ Method of use U-2628 Feb 1, 2039
US 12396953 ↗ Method of use U-2628 Feb 1, 2039
US 12396953 ↗ Method of use U-2628 Feb 1, 2039
US 10278923 ↗ Drug substance U-2628 May 2, 2034
US 10278923 ↗ Drug substance U-2628 May 2, 2034
US 10278923 ↗ Drug substance U-2628 May 2, 2034
US 9278123 ↗ Drug substance U-2628 Dec 16, 2031
US 11033499 ↗ Method of use U-2628 Jun 19, 2033
US 11033499 ↗ Method of use U-2628 Jun 19, 2033
US 11033499 ↗ Method of use U-2628 Jun 19, 2033
US 11033499 ↗ Method of use U-2628 Jun 19, 2033
US 11033499 ↗ Method of use U-2628 Jun 19, 2033
US 11033499 ↗ Method of use U-2628 Jun 19, 2033
US 10933120 ↗ Drug product — Mar 15, 2033
US 11759501 ↗ Drug product — Mar 15, 2033
US 11382957 ↗ Drug substance — Dec 16, 2031
US 10960052 ↗ Drug product — Dec 16, 2031
US 11759502 ↗ Drug product — Mar 15, 2033
US 11759503 ↗ Drug product — Mar 15, 2033
US 11759503 ↗ Drug product — Mar 15, 2033
US 11759503 ↗ Drug product — Mar 15, 2033
US 10933120 ↗ Drug product — Mar 15, 2033
US 10960052 ↗ Drug product — Dec 16, 2031
US 10086047 ↗ Drug product — Dec 16, 2031
US 10960052 ↗ Drug product — Dec 16, 2031
US 11382957 ↗ Drug product — Dec 16, 2031
US 12594326 ↗ Drug product — Mar 15, 2033
US 10933120 ↗ Drug product — Mar 15, 2033
US 12594326 ↗ Drug product — Mar 15, 2033
US 11759502 ↗ Drug product — Mar 15, 2033
US 11382957 ↗ Drug product — Dec 16, 2031
US 11382957 ↗ Drug substance — Dec 16, 2031
US 10086047 ↗ Drug product — Dec 16, 2031
US 11382957 ↗ Drug product — Dec 16, 2031
US 11759501 ↗ Drug product — Mar 15, 2033
US 11382957 ↗ Drug substance — Dec 16, 2031
US 11759501 ↗ Drug product — Mar 15, 2033
US 11759502 ↗ Drug product — Mar 15, 2033
US 12594326 ↗ Drug product — Mar 15, 2033
US 10086047 ↗ Drug product — Dec 16, 2031
FDA exclusivity
CodeWhat it grantsExpires
I-976New indication (3-year)Oct 17, 2028
I-976New indication (3-year)Oct 17, 2028
I-976New indication (3-year)Oct 17, 2028
I-976New indication (3-year)Oct 17, 2028
I-976New indication (3-year)Oct 17, 2028
I-976New indication (3-year)Oct 17, 2028
Common questions
Is there a generic version of OZEMPIC 9 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for OZEMPIC 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.

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

Medicare Part D (outpatient prescription) spending for Ozempic — 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 Ozempic. 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
$3.96B
Claims incl. refills
2.9M
Beneficiaries
1.5M
Spend / beneficiary
$2,716.05
Spend / claim
$1,387.09
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00169-1709-30 You're viewing this 30 TABLET in 1 BOTTLE, PLASTIC (0169-1709-30) 2026-04-27 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

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

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

It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). • RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

🎯 Indications and Usage 132 words ▾

1 INDICATIONS AND USAGE RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

( 1 ) • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis. • Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water. ( 2.1 ) • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.

( 2.1 ) • After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. ( 2.1 ) • See the Full Prescribing Information for instructions on switching between RYBELSUS and OZEMPIC tablets ( 2.3 ) and from OZEMPIC injections to RYBELSUS or OZEMPIC tablets. ( 2.4 ) Recommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets ( 2.2 ) RYBELSUS ( 2.2 ) • Day 1 to 30: Recommended starting dosage is 3 mg orally once daily for 30 days (this dosage is not effective for glycemic control) • Days 31 to 60: Increase the dosage to 7 mg orally once daily. • On Day 61 or thereafter, if: ( 2.2 ) o No additional glycemic control is needed, maintain the dosage at 7 mg orally once daily. o Additional glycemic control is needed, increase the dosage to 14 mg orally once daily.

OZEMPIC Tablets ( 2.2 ) • Day 1 to 30: Recommended starting dosage is 1.5 mg orally once daily for 30 days (this dosage is not effective for glycemic control). • Days 31 to 60: Increase the dosage to 4 mg orally once daily. • On Day 61 or thereafter, if: ( 2.2 ) o No additional glycemic control is needed, maintain the dosage at 4 mg orally once daily. o Additional glycemic control is needed, increase the dosage to 9 mg orally once daily.

2.1Important Administration Instructions • RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis. • Take one RYBELSUS or OZEMPIC tablet orally once daily on an empty stomach in the morning with water (up to 4 ounces of water). Do not take RYBELSUS or OZEMPIC tablets with other liquids besides water [see Clinical Pharmacology ( 12.3 )] . • Do not take more than one tablet per day. • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. • After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications [see Clinical Pharmacology ( 12.3 )] . • If a dose is missed, skip the missed dose and take the next dose the following day.

2.2Recommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets RYBELSUS: Recommended Dosage Follow the RYBELSUS starting, escalation, and maintenance dosage described below to reduce the risk of gastrointestinal (GI) adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 )] : • Starting Dosage (Initiation Phase) (Days 1 to 30) : The recommended starting dosage is 3 mg orally once daily (this dosage is not effective for glycemic control). • Escalation and Maintenance Dosage (Days 31 and beyond) : o Days 31 to 60: Increase the dosage to 7 mg orally once daily. o On Day 61 or thereafter, if: ▪ No additional glycemic control is needed, maintain the dosage at 7 mg orally once daily. ▪ Additional glycemic control is needed, increase the dosage to 14 mg orally once daily.

OZEMPIC Tablets: Recommended Dosage Follow the OZEMPIC tablets starting, escalation, and maintenance dosage described below to reduce the risk of GI adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 )] : • Starting Dosage (Initiation Phase) (Days 1 through 30) : The recommended starting dosage is 1.5 mg orally once daily (this dosage is not effective for glycemic control). • Escalation and Maintenance Dosage (Days 31 and beyond) : o Days 31 to 60: Increase the dosage to 4 mg orally once daily. o On Day 61 or thereafter, if: ▪ No additional glycemic control is needed, maintain the dosage at 4 mg orally once daily. ▪ Additional glycemic control is needed, increase the dosage to 9 mg orally once daily.

2.3 Switc…

💊 Dosage Forms and Strengths 169 words ▾

3 DOSAGE FORMS AND STRENGTHS RYBELSUS (semaglutide) tablets are available as: • 3 mg: white to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side. • 7 mg: white to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side. • 14 mg: white to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side. OZEMPIC (semaglutide) tablets are available as: • 1.5 mg: white to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side. • 4 mg: white to light yellow, round shaped debossed with “4” on one side and “novo” on the other side. • 9 mg: white to light yellow, round shaped debossed with “9” on one side and “novo” on the other side. • RYBELSUS tablets: 3 mg, 7 mg and 14 mg ( 3 ) • OZEMPIC tablets: 1.5 mg, 4 mg and 9 mg ( 3 )

⛔ Contraindications 118 words ▾

4 CONTRAINDICATIONS RYBELSUS and OZEMPIC tablets are contraindicated in patients with: • A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . • A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS or OZEMPIC tablets. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with semaglutide tablets [see Warnings and Precautions ( 5.7 )] . • Personal or family history of MTC or in patients with MEN 2 syndrome type 2 ( 4 ) • Prior serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS or OZEMPIC tablets. Discontinue if pancreatitis is suspected. ( 5.2 ) • Diabetic Retinopathy Complications : Has been reported in a cardiovascular outcomes trial with semaglutide injection.

Patients with a history of diabetic retinopathy should be monitored. ( 5.3 ) • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin : May increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin secretagogue or insulin may be necessary.

( 5.4 ) • Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) • Severe Gastrointestinal Adverse Reactions : Use of RYBELSUS or OZEMPIC tablets has been associated with gastrointestinal adverse reactions, sometimes severe. RYBELSUS and OZEMPIC tablets are not recommended in patients with severe gastroparesis.

( 5.6 ) • Hypersensitivity Reactions : Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue RYBELSUS or OZEMPIC tablets if hypersensitivity reactions occur and monitor until signs and symptoms resolve. ( 5.7 ) • Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.

( 5.8 ) • Pulmonary Aspiration During General Anesthesia or Deep Sedation : Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 )

5.1Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of RYBELSUS or OZEMPIC tablets and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS or OZEMPIC tablets. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L.

If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2Acute Pancreatitis Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide tablets [see Adverse Reactions ( 6 )] . After initiation of RYBELSUS or OZEMPIC tablets, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be ac…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Diabetic Retinopathy Complications [see Warnings and Precautions ( 5.3 )] • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-457-7455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OZEMPIC tablets (1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration ( 2.2 )] and RYBELSUS (3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration ( 2.2 )] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS in adult patients with type 2 diabetes mellitus [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14 )] .

Below is a display of the safety results of the adequate and well-controlled studies of RYBELSUS (referred to below as semaglutide tablets) in adult patients with type 2 diabetes mellitus. Pool of Placebo-Controlled Trials The data in Table 2 are derived from 2 placebo-controlled trials in adult patients with type 2 diabetes mellitus [see Clinical Studies ( 14 )] . These data reflect exposure of 1,071 patients to semaglutide tablets (3 mg, 7, mg or 14 mg orally once daily) with a mean duration of exposure of 41.8 weeks.

The mean age of patients was 58 years, 3.9% were 75 years or older and 52% were male. In these trials, 63% were White, 6% were Black or African American and 27% were Asian; 19% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 mellitus diabetes for an average of 9.4 years and had a mean HbA 1c of 8.1%.

At baseline, 20.1% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m 2 ) in 66.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m 2 ) in 32.4% and moderately impaired (eGFR 30 to 60 mL/min/1.73m 2 ) in 1.4% of patients. Pool of Placebo- and Active-Controlled Trials The occurrence of adverse reactions was also evaluated in a larger pool of adult patients with type 2 diabetes mellitus participating in 9 placebo- and active-controlled trials [see Clinical Studies ( 14 )] .

In this pool, 4,116 patients with type 2 diabetes mellitus were treated with semaglutide tablets for a mean duration of 59.8 weeks. The mean age of patients was 58 years, 5% were 75 years or older and 55% were male. In these trials, 65% were White, 6% were Black or African American and 24% were Asian; 15% identified as Hispanic or Latino ethnicity.

At baseline, patients had type 2 diabetes mellitus for an average of 8.8 years and had a mean HbA 1c of 8.2%. At baseline, 16.6% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m 2 ) in 65.9%, mildly impaired (eGFR 60 to 90 mL/min/1.73m 2 ) in 28.5% and moderately impaired (eGFR 30 to 60 mL/min/1.73…

🔄 Drug Interactions 216 words ▾

7 DRUG INTERACTIONS Other Oral Drugs : RYBELSUS and OZEMPIC tablets delay gastric emptying. Consider increased clinical or laboratory monitoring when co-administered with other oral medications that have a narrow therapeutic index or that require clinical monitoring. ( 7.2 )

7.1Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin Semaglutide stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving RYBELSUS or OZEMPIC tablets in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. When initiating RYBELSUS or OZEMPIC tablets, consider reducing the dosage of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.1 )] .

7.2Other Oral Drugs Semaglutide cause a delay of gastric emptying and thereby has the potential to impact the absorption of other oral drugs. Levothyroxine exposure was increased 33% (90% CI: 1.25 to 1.42) when administered with semaglutide tablets in a drug interaction study [see Clinical Pharmacology ( 12.3 )] . When using RYBELSUS or OZEMPIC tablets concomitantly with other oral drugs that have a narrow therapeutic index or that require clinical monitoring, consider increased clinical or laboratory monitoring [see Dosage and Administration ( 2 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy : See Pregnancy subsection. ( 8.1 ) • Lactation : Breastfeeding not recommended. ( 8.2 ) • Females and Males of Reproductive Potential : Discontinue RYBELSUS or OZEMPIC tablets in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide. ( 8.3 )

8.1Pregnancy Risk Summary Available data with semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations ). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.

RYBELSUS or OZEMPIC tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at exposure below the MRHD (rabbit) and ≥10-fold the MRHD (monkey).

These findings coincided with a marked maternal body weight loss in both animal species (see Data ). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20% to 25% in women with an HbA 1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease Associated Maternal and Fetal Risk : Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity. Data Animal Data : In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17.

In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.06-, 0.6- and 4.4-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19.

Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures. In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.9-, 9.9- and 29-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50.

Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥9X human exposure). In a pre- and postnatal development study in pregnant cynomolgus monkeys, sub…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data with semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations ). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.

RYBELSUS or OZEMPIC tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at exposure below the MRHD (rabbit) and ≥10-fold the MRHD (monkey).

These findings coincided with a marked maternal body weight loss in both animal species (see Data ). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20% to 25% in women with an HbA 1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease Associated Maternal and Fetal Risk : Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity. Data Animal Data : In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17.

In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.06-, 0.6- and 4.4-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19.

Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures. In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.9-, 9.9- and 29-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50.

Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥9X human exposure). In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.3-, 6.4- and 14-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to…

🧒 Pediatric Use 19 words ▾

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

🧓 Geriatric Use 109 words ▾

8.5Geriatric Use In the pool of glycemic control trials, 1,229 (30%) patients treated with semaglutide tablets were 65 years of age and over and 199 (5%) patients treated with semaglutide tablets were 75 years of age and over [see Clinical Studies ( 14 )] . In Trial 8, one of the CV outcomes trials, 891 (56%) patients treated with semaglutide tablets were 65 years of age and over and 200 (13%) patients treated with semaglutide tablets were 75 years of age and over. No overall differences in safety or effectiveness for semaglutide tablets have been observed between patients 65 years of age and older and younger adult patients.

🆘 Overdosage 62 words ▾

10 OVERDOSAGE In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.

The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner.

Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

12.2Pharmacodynamics The pharmacodynamic evaluations described below were in patients with type 2 diabetes mellitus who received once-weekly subcutaneous injections of placebo or semaglutide injection over 12 weeks (semaglutide injection-treated patients were started on lower dosages and then titrated up to 1 mg once weekly). RYBELSUS and OZEMPIC tablets are not approved for subcutaneous use. Fasting and Postprandial Glucose Semaglutide reduces fasting and postprandial glucose concentrations.

In patients with type 2 diabetes mellitus, treatment with semaglutide injection 1 mg resulted in reductions in glucose in terms of absolute change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2-hour postprandial glucose and 30 mg/dL (22%) for mean 24-hour glucose concentration. Insulin Secretion Both first- and second-phase insulin secretion are increased in patients with type 2 diabetes mellitus treated with semaglutide compared with placebo. Glucagon Secretion Semaglutide lowers the fasting and postprandial glucagon concentrations.

Glucose dependent insulin and glucagon secretion Semaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner. During induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes mellitus. Gastric emptying Semaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially.

Cardiac Electrophysiology The effect of subcutaneously administered semaglutide on cardiac repolarization was tested in a thorough QTc trial. At an average exposure level 4-fold higher than that of the maximum recommended dose of semaglutide tablets, semaglutide does not prolong QTc intervals to any clinically relevant extent.

12.3Pharmacokinetics Semaglutide estimated mean steady-state concentration was 6.7 nmol/L and 14.6 nmol/L following once daily oral administration of 7 mg and 14 mg of RYBELSUS, respectively, in patients with type 2 diabetes mellitus. Semaglutide exposures increased in a dose-proportional manner. Steady-state exposure was achieved following 4 to 5 weeks of semaglutide tablets oral administration.

Absorption RYBELSUS and OZEMPIC tablets are co-formulated with SNAC which facilitates the absorption of semaglutide after oral administration. The absorption of semaglutide predominantly occurs in the stomach. Semaglutide estimated absolute bioavailability was approximately: • 0.4% to 1% after oral administration of 3 mg, 7 mg and 14 mg of RYBELSUS. • 1% to 2% after oral administration of 1.5 mg, 4 mg and 9 mg of OZEMPIC tablets.

Semaglutide maximum concentration was reached approximately 1-hour after oral administration of semaglutide tablets. Effect…

🧬 Mechanism of Action 144 words ▾

12.1Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.

The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner.

Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RYBELSUS strengths are available as follows: Tablet Strength Description Package Configuration NDC Number 3 mg White to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side Bottle of 30 tablets 0169-4303-30 7 mg White to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side Bottle of 30 tablets 0169-4307-30 14 mg White to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side Bottle of 30 tablets 0169-4314-30 OZEMPIC tablet strengths are available as follows: Tablet Strength Description Package Configuration NDC Number 1.5 mg White to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side Bottle of 30 tablets 0169-1715-30 4 mg White to light yellow, round shaped debossed with “4” on one side and “novo” on the other side Bottle of 30 tablets 0169-1704-30 9 mg White to light yellow, round shaped debossed with “9” on one side and “novo” on the other side Bottle of 30 tablets 0169-1709-30 Storage and Handling Store RYBELSUS and OZEMPIC tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store and dispense in the original bottle. Store tablets in the original bottle until use to protect tablets from moisture. Store product in a dry place away from moisture.

📋 Description 161 words ▾

11 DESCRIPTION RYBELSUS and OZEMPIC tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid.

Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C 187 H 291 N 45 O 59 and the molecular weight is 4113.58 g/mol.

Structural formula: Semaglutide is a white to almost white hygroscopic powder. RYBELSUS tablets contain 3 mg, 7 mg or 14 mg of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC). OZEMPIC tablets contain 1.5 mg, 4 mg or 9 mg of semaglutide and the following inactive ingredients: magnesium stearate and SNAC. structural_formula

💬 Information for Patients ~3 min read ▾

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

Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue RYBELSUS or OZEMPIC tablets promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )] . Diabetic Retinopathy Complications Inform patients to contact their physician if changes in vision are experienced during treatment with RYBELSUS or OZEMPIC tablets [see Warnings and Precautions ( 5.3 )] .

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Inform patients that the risk of hypoglycemia is increased when RYBELSUS or OZEMPIC tablets are used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.4 )]. Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions.

Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.5 )] . Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions.

Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.6 )]. Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of semaglutide tablets. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking RYBELSUS or OZEMPIC tablets and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.7 )] .

Acute Gallbladder Disease Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions ( 5.8 )] . Pulmonary Aspiration During General Anesthesia or Deep Sedation : Inform patients that RYBELSUS or OZEMPIC tablets may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures.

Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS or OZEMPIC tablets [see Warnings and Precautions ( 5.9 )]. Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in Specific Populations ( 8.1 , 8.3 )] .

Lactation RYBELSUS and OZEMPIC tablets pass into breast milk, and it is not known how it affects your baby. Advise females not to breastfeed during treatment with RYBELSUS or OZEMPIC tablets [see Use in Specific Populations ( 8.2 )] . Females and Males of Reproductive Potential Discontinue RYBELSUS or OZEMPIC tablets at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations ( 8.3 )] .

Marketed by: Novo Nordisk Inc. Plainsboro, NJ 08536 For add…

💬 Medication Guide ~3 min read ▾

Medication Guide MEDICATION GUIDE RYBELSUS ® (reb-EL-sus) (semaglutide) tablets, for oral use OZEMPIC ® (oh-ZEM-pick) (semaglutide) tablets, for oral use Read this Medication Guide before you start using RYBELSUS or OZEMPIC tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about RYBELSUS and OZEMPIC tablets? RYBELSUS and OZEMPIC tablets may cause serious side effects, including: • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS and OZEMPIC tablets and other medicines that work like RYBELSUS and OZEMPIC tablets caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS and OZEMPIC tablets will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. • Do not use RYBELSUS or OZEMPIC tablets if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What are RYBELSUS and OZEMPIC tablets? RYBELSUS and OZEMPIC tablets are prescription medicines used: • along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. • to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus who are at high risk for these events. It is not known if RYBELSUS and OZEMPIC tablets are safe and effective for use in children.

Do not use RYBELSUS or OZEMPIC tablets if: • you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). • you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS or OZEMPIC tablets. See the end of this Medication Guide for a complete list of ingredients in RYBELSUS and OZEMPIC tablets. See “What are the possible side effects of RYBELSUS and OZEMPIC tablets?” for symptoms of a serious allergic reaction .

Before using RYBELSUS or OZEMPIC tablets, tell your healthcare provider if you have any other medical conditions, including if you: • have or have had problems with your pancreas or kidneys. • have a history of vision problems related to your diabetes. • are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). • are pregnant or plan to become pregnant. It is not known if RYBELSUS and OZEMPIC tablets will harm your unborn baby. You should stop using RYBELSUS or OZEMPIC tablets 2 months before you plan to become pregnant.

Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. • are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS or OZEMPIC tablets. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

RYBELSUS and OZEMPIC tablets may affect the way some medicines work, and some medicines may affect the way RYBELSUS and OZEMPIC tablets work. Before using RYBELSUS or OZEMPIC tablets, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take RYBELSUS or OZEMPIC tablets? • Take RYBE…

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