Active ingredient
Azilsartan
6 finished FDA listings contain Azilsartan as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- AZILSARTAN, AZILSARTAN KAMEDOXOMIL, AZILSARTAN MEDOXOMIL
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 40 mg/1 · 80 mg/1
- Brand names in FDA listings
- Azilsartan Medoxomil, Edarbi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1091643
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 200796 | AZURITY | 2011-02-25 | 4 |
| ANDA 214489 | LUPIN | 2022-07-20 | 2 |
Official labeling on DailyMed
- AZILSARTAN MEDOXOMIL TABLET [LUPIN PHARMACEUTICALS, INC.] · version 7 · 2026-05-14
- AZILSARTAN MEDOXOMIL (AZILSARTAN KAMEDOXOMIL) TABLET [WILSHIRE PHARMACEUTICALS, INC.] · version 1 · 2026-04-27
- EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [AZURITY PHARMACEUTICALS, INC.] · version 17 · 2024-01-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.