Active ingredient
Candesartan
40 finished FDA listings contain Candesartan as their only active ingredient; 16 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CANDESARTAN CILEXETIL
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 16 mg/1 · 32 mg/1 · 4 mg/1 · 8 mg/1
- Brand names in FDA listings
- Atacand
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 214354
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 020838 | ANI PHARMS | 1998-06-04 | 12 |
| ANDA 078702 | MYLAN | 2013-05-03 | 4 |
| ANDA 203813 | MACLEODS PHARMS | 2016-12-05 | 7 |
| ANDA 209119 | ALEMBIC | 2017-06-20 | 2 |
| ANDA 091390 | ZYDUS LIFESCIENCES | 2017-08-23 | 8 |
| ANDA 210302 | ALEMBIC | 2018-12-04 | 7 |
Official labeling on DailyMed
- CANDESARTAN CILEXETIL TABLET [VIONA PHARMACEUTICALS INC] · version 4 · 2026-09-09
- CANDESARTAN CILEXETIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 2 · 2026-02-06
- CANDESARTAN TABLET [BRYANT RANCH PREPACK] · version 1 · 2026-02-06
- CANDESARTAN CILEXETIL TABLET [ZYDUS LIFESCIENCES LIMITED] · version 5 · 2026-01-07
- ATACAND (CANDESARTAN CILEXETIL) TABLET [ANI PHARMACEUTICALS, INC.] · version 5 · 2025-12-23
- CANDESARTAN CILEXETIL TABLET [ANI PHARMACEUTICALS, INC.] · version 2 · 2025-12-23
- CANDESARTAN TABLET [NORTHSTAR RXLLC] · version 2 · 2025-11-27
- CANDESARTAN CILEXETIL TABLET [MYLAN PHARMACEUTICALS INC.] · version 4 · 2024-01-26
- CANDESARTAN CILEXETIL TABLET [BRYANT RANCH PREPACK] · version 100 · 2023-09-27
- CANDESARTAN CILEXETIL TABLET [ALEMBIC PHARMACEUTICALS LIMITED] · version 4 · 2023-02-02
- CANDESARTAN CILEXETIL TABLET [ALEMBIC PHARMACEUTICALS LIMITED] · version 3 · 2023-01-16
- CANDESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 6 · 2023-01-02
Showing the 12 most recent of 14 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.