Active ingredient
Exenatide
4 finished FDA listings contain Exenatide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EXENATIDE
- Dosage forms
- Injection
- Routes
- Subcutaneous
- Manufacturers / labelers
- 2
- Strengths listed
- 250 ug/ml
- Brand names in FDA listings
- Byetta
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 60548
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 021773 | ASTRAZENECA AB | 2005-04-28 | 2 |
| ANDA 206697 | AMNEAL | 2024-11-19 | 2 |
Official labeling on DailyMed
- EXENATIDE INJECTION [AMNEAL PHARMACEUTICALS LLC] · version 17 · 2026-06-30
- BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP] · version 26 · 2025-09-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.