Active ingredient
Semaglutide
24 finished FDA listings contain Semaglutide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SEMAGLUTIDE
- Dosage forms
- Injection, Solution, Tablet
- Routes
- Oral, Subcutaneous
- Manufacturers / labelers
- 2
- Strengths listed
- .25 mg/.5ml · .5 mg/.5ml · .68 mg/ml · 1 mg/.5ml · 1.34 mg/ml · 1.5 mg/1 · 1.7 mg/.75ml · 14 mg/1 · 2.4 mg/.75ml · 2.68 mg/ml · 25 mg/1 · 3 mg/1 · 3.2 mg/ml · 4 mg/1 · 7 mg/1 · 7.2 mg/.75ml · 9 mg/1
- Brand names in FDA listings
- Ozempic, Rybelsus, Wegovy
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1991302
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 209637 | NOVO | 2017-12-05 | 6 |
| NDA 213051 | NOVO | 2019-09-20 | 6 |
| NDA 215256 | NOVO | 2021-06-04 | 8 |
| NDA 218316 | NOVO | 2025-12-22 | 4 |
Official labeling on DailyMed
- OZEMPIC (ORAL SEMAGLUTIDE) TABLET RYBELSUS (ORAL SEMAGLUTIDE) TABLET [NOVO NORDISK PHARMACEUTICAL INDUSTRIES, LP] · version 14 · 2026-08-19
- OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 1 · 2026-07-31
- WEGOVY (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 6 · 2024-04-25
- OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 3 · 2023-11-23
- OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 6 · 2023-11-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.