Active ingredient
Enalapril
106 finished FDA listings contain Enalapril as their only active ingredient; 5 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ENALAPRIL MALEATE
- Dosage forms
- Solution, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 33
- Strengths listed
- 1 mg/ml · 10 mg/1 · 2.5 mg/1 · 20 mg/1 · 5 mg/1
- Brand names in FDA listings
- Enalapril Maleate, Enalapril Maleate Oral Solution, Epaned, Vasotec
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3827
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 018998 | BAUSCH | 1985-12-24 | 9 |
| ANDA 075479 | HERITAGE PHARMA | 2000-08-22 | 21 |
| ANDA 075459 | SANDOZ INC | 2000-08-22 | 2 |
| ANDA 075483 | SENORES PHARMS | 2000-08-22 | 4 |
| ANDA 075496 | SANDOZ INC | 2000-08-22 | 3 |
| ANDA 075657 | TARO | 2001-01-23 | 19 |
| ANDA 075178 | AIPING PHARM INC | 2001-03-23 | 6 |
| NDA 208686 | AZURITY | 2016-09-20 | 2 |
| ANDA 212408 | BIONPHARMA | 2021-08-10 | 1 |
| ANDA 214467 | ANNORA PHARMA | 2022-02-24 | 2 |
| ANDA 213714 | ALKEM LABS LTD | 2022-03-30 | 1 |
| ANDA 212894 | AMNEAL | 2022-06-29 | 1 |
| ANDA 213273 | PRINSTON INC | 2022-07-07 | 26 |
| ANDA 216458 | AUROBINDO PHARMA | 2024-01-08 | 1 |
| ANDA 218531 | UNIQUE PHARM | 2024-09-19 | 8 |
Official labeling on DailyMed
- ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-02
- ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.] · version 5 · 2026-09-02
- ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.] · version 4 · 2026-09-02
- ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.] · version 4 · 2026-08-31
- ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 2 · 2026-08-28
- ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.] · version 7 · 2026-08-28
- ENALAPRIL MALEATE TABLET [COUPLER LLC] · version 1 · 2026-08-28
- ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 12 · 2026-08-28
- ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-08-25
- ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-08-24
- ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK] · version 103 · 2026-08-21
- ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.] · version 8 · 2026-08-12
Showing the 12 most recent of 66 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.