Active ingredient
Trandolapril
14 finished FDA listings contain Trandolapril as their only active ingredient; 4 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TRANDOLAPRIL
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 1 mg/1 · 2 mg/1 · 4 mg/1
- Brand names in FDA listings
- Trandolapril
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 38454
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 078438 | AUROBINDO PHARMA | 2007-06-12 | 7 |
| ANDA 077522 | LUPIN | 2007-06-12 | 4 |
| ANDA 078508 | EPIC PHARMA | 2008-06-18 | 3 |
Official labeling on DailyMed
- TRANDOLAPRIL TABLET [LUPIN PHARMACEUTICALS, INC.] · version 13 · 2025-11-17
- TRANDOLAPRIL TABLET [BRYANT RANCH PREPACK] · version 5 · 2025-09-08
- TRANDOLAPRIL TABLET [BRYANT RANCH PREPACK] · version 5 · 2024-06-03
- TRANDOLAPRIL TABLET [RISING PHARMA HOLDINGS, INC.] · version 7 · 2024-04-24
- TRANDOLAPRIL TABLET [AUROBINDO PHARMA LIMITED] · version 19 · 2024-04-22
- TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] · version 8 · 2018-07-26
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.