Active ingredient
Captopril
47 finished FDA listings contain Captopril as their only active ingredient; 4 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CAPTOPRIL
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 13
- Strengths listed
- 100 mg/1 · 12.5 mg/1 · 25 mg/1 · 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1998
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 |
|---|---|---|---|
| ANDA 074505 | HIKMA INTL PHARMS | 1996-02-13 | 11 |
| ANDA 074477 | PRINSTON INC | 1996-02-13 | 4 |
| ANDA 074677 | ANDAS 5 HOLDING | 1997-05-30 | 13 |
| ANDA 074737 | COREPHARMA | 1998-10-28 | 7 |
| ANDA 212809 | AJANTA PHARMA LTD | 2019-12-13 | 8 |
| ANDA 214442 | AIPING PHARM INC | 2023-01-27 | 4 |
Official labeling on DailyMed
- CAPTOPRIL TABLET [AMICI PHARMA, INC.] · version 4 · 2026-09-15
- CAPTOPRIL TABLET [BRYANT RANCH PREPACK] · version 103 · 2026-05-22
- CAPTOPRIL TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-05-15
- CAPTOPRIL TABLET [MAJOR PHARMACEUTICALS] · version 7 · 2026-05-11
- CAPTOPRIL TABLET [SOLCO HEALTHCARE US, LLC] · version 2 · 2026-04-03
- CAPTOPRIL TABLET [AIPING PHARMACEUTICAL, INC.] · version 1 · 2026-04-02
- CAPTOPRIL TABLET [AJANTA PHARMA USA INC.] · version 3 · 2026-01-01
- CAPTOPRIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 5 · 2025-12-15
- CAPTOPRIL TABLET [METHOD PHARMACEUTICALS LLC] · version 3 · 2025-12-12
- CAPTOPRIL TABLET [BRYANT RANCH PREPACK] · version 1 · 2025-06-30
- CAPTOPRIL TABLET [AVKARE] · version 1 · 2025-04-24
- CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] · version 29 · 2025-03-24
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.