Prescription medicine
Semaglutide Brand names: Wegovy, Ozempic, Rybelsus
Semaglutide (Ozempic) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $331.99 per mL (Ozempic 0.25-0.5 mg/dose (2 mg/3 mL) pen) in the October 7, 2026 NADAC survey.
- No generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the semaglutide FDA label on DailyMed (effective July 30, 2026, A-S Medication Solutions); the NDA 209637 record on Drugs@FDA; every semaglutide label on DailyMed.
Highlights of the record
FDA label of July 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 OZEMPIC causes 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 )].
OZEMPIC is 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 OZEMPIC 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 OZEMPIC [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. […]
Used for
From the label: indications and usageOZEMPIC is indicated:
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 1.5 mg
- 3 mg
- 4 mg
- 7 mg
- 9 mg
- 14 mg
- 25 mg
- 0.25 mg/.5ml
- 0.5 mg/.5ml
- 0.68 mg/ml
- 1 mg/.5ml
- 1.34 mg/ml
Injection (solution); tablet.
On the market
- Earliest approval on file
- December 5, 2017 Ozempic, Novo; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- February 17, 2041 Ozempic injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $331.99 per mL Ozempic 0.25-0.5 mg/dose (2 mg/3 mL) pen
- Shortage (FDA)
- None current 3 past records; a resolved shortage below
- Recalls by its makers (FDA)
- 4 since 2021 0 Class I among all firms' recalls; latest December 19, 2025; 30 more by firms not listed as its makers
- FAERS reports
- 73,001 through July 30, 2026
What is semaglutide used for?
From the label: indications and usageOZEMPIC is 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 events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated:
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. […]
Conditions named in the indications of semaglutide's FDA labels, with every medicine labeled for each:
From other semaglutide labelsWeight management: • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. o adults with overweight in the presence of at least one weight-related comorbid condition.
FDA pharmacologic class: GLP-1 Receptor Agonist.
Source: FDA drug label (Ozempic), NDA209637 (Novo), as published by A-S Medication Solutions, effective July 30, 2026 (SPL set 42bdd912-2393-44c4-b7e0-47672ca28991), via openFDA; the full label on DailyMed
What does the patient leaflet for semaglutide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OZEMPIC?OZEMPIC 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, OZEMPIC and medicines that work like OZEMPIC caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. • Do not use OZEMPIC 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).
Source: FDA drug label (Ozempic), NDA209637 (Novo), as published by A-S Medication Solutions, effective July 30, 2026 (SPL set 42bdd912-2393-44c4-b7e0-47672ca28991), via openFDA; the full label on DailyMed
Is there a generic for semaglutide (Ozempic)?
No generic semaglutide is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 22 patents for Ozempic injection: the compound patent runs to December 5, 2031, and the last listed entry to February 17, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for semaglutide (Ozempic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $331.99 per mL (Ozempic 0.25-0.5 mg/dose (2 mg/3 mL) pen), up 3% from $322.31 on October 8, 2025. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ozempic 0.25-0.5 mg/dose (2 mg/3 mL) pen | Brand | $331.99 per mL | $995.97 per pen (several doses) | +3% |
| Ozempic 1 mg/dose (4 mg/3 mL) pen | Brand | $331.90 per mL | $995.70 per pen (several doses) | +3% |
| Ozempic 1.5 mg tablet | Brand | $33.13 per tablet | $993.79 | n/a |
| Ozempic 2 mg/dose (8 mg/3 mL) pen | Brand | $331.97 per mL | $995.92 per pen (several doses) | +3% |
| Ozempic 4 mg tablet | Brand | $33.18 per tablet | $995.39 | n/a |
| Ozempic 9 mg tablet | Brand | $33.18 per tablet | $995.36 | n/a |
| Rybelsus 14 mg tablet | Brand | $33.19 per tablet | $995.66 | +3% |
| Rybelsus 3 mg tablet | Brand | $33.19 per tablet | $995.70 | +3% |
| Rybelsus 7 mg tablet | Brand | $33.19 per tablet | $995.80 | +3% |
| Wegovy 0.25 mg/0.5 mL pen | Brand | $653.29 per mL | $326.65 per single-dose pen | +0.1% |
| Wegovy 0.5 mg/0.5 mL pen | Brand | $653.27 per mL | $326.64 per single-dose pen | +0.1% |
| Wegovy 1 mg/0.5 mL pen | Brand | $653.04 per mL | $326.52 per single-dose pen | +0.1% |
| Wegovy 1.5 mg tablet | Brand | $43.52 per tablet | $1,305.56 | n/a |
| Wegovy 1.7 mg/0.75 mL pen | Brand | $435.56 per mL | $326.67 per single-dose pen | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is semaglutide in shortage?
No semaglutide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated June 4, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Rybelsus, Tablet, 14 mg (NDC 0169-4314-30) | Novo Nordisk, Inc. | To Be Discontinued | June 4, 2026 |
| Rybelsus, Tablet, 3 mg (NDC 0169-4303-30) | Novo Nordisk, Inc. | To Be Discontinued | June 4, 2026 |
| Rybelsus, Tablet, 7 mg (NDC 0169-4307-30) | Novo Nordisk, Inc. | To Be Discontinued | June 4, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has semaglutide been in shortage before?
The FDA determined that the shortage of semaglutide injection was resolved on February 21, 2025; the shortage had been listed since March 2022.
The shortage file openFDA publishes does not keep every shortage the FDA resolved before it; this history is from the FDA's own page on it. Status checked October 8, 2026.
Source: the FDA's page on the GLP-1 shortage and compounding, which records the resolution of February 21, 2025
Has semaglutide been recalled?
The FDA's Enforcement Report lists 34 recalls naming semaglutide since 2021: 0 Class I (the most serious), 34 Class II, 0 Class III; 32 still ongoing. 30 of them are by firms that FDA's NDC Directory does not list as a maker of semaglutide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2026 | Class II | Apollo Care, LLC not a listed maker | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material |
| February 13, 2026 | Class II | Harbin Jixianglong Biotech Co., Ltd. not a listed maker | CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution |
| December 19, 2025 | Class II | Novo Nordisk Inc. | Presence of Particulate Matter: Hair was found in a prefilled syringe |
| October 15, 2025 | Class II | ProRx LLC not a listed maker | Lack of Assurance of Sterility |
| July 30, 2025 | Class II | GenoGenix LLC not a listed maker | Lack of Assurance of Sterility |
| July 9, 2025 | Class II | Boothwyn Pharmacy LLC not a listed maker | Subpotent Drug |
| May 21, 2025 | Class II | Thrive Health and Wellness, LLC, dba Thrive Health … not a listed maker | Lack of Assurance of Sterility |
| April 9, 2025 | Class II | Cardinal Health Inc. | Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the semaglutide label say about other medicines?
The semaglutide label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Levothyroxine | drug interactions | 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 )]. |
| Liraglutide | warnings and precautions | 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. |
Source: FDA drug label (Ozempic), NDA209637 (Novo), as published by A-S Medication Solutions, effective July 30, 2026 (SPL set 42bdd912-2393-44c4-b7e0-47672ca28991), via openFDA; the full label on DailyMed
What do FAERS reports show for semaglutide?
The FDA Adverse Event Reporting System holds 73,001 reports that list semaglutide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,270 are coded as a death and 14,338 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (20,013, against a median of 3,515 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as semaglutide?
35 other medicines are given the same way (oral) and in the same FDA class as semaglutide or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Orforglipron | Weight management | none listed | $20.89 per tablet 0.8 mg tablet | No current entry |
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| Dapagliflozin and metformin | Type 2 diabetes | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Metformin and sitagliptin | Type 2 diabetes | 4 labelers | $1.76 per tablet 50 mg-1,000 mg tablet | No current entry |
Every medicine labeled for the same conditions as semaglutide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does semaglutide compare with medicines for the same use?
6 side-by-side pages set semaglutide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to semaglutide
- 35 medicines for the same use
- Other GLP-1 receptor agonists
- the pharmacologic class, with prices and generics
- Semaglutide side effects
- the label's list beside FAERS reports
- Semaglutide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other