Active ingredient
Isradipine
5 finished FDA listings contain Isradipine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ISRADIPINE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 2.5 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 33910
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 077317 | WATSON LABS TEVA | 2006-01-05 | 3 |
| ANDA 077169 | ELITE LABS INC | 2006-04-24 | 2 |
Official labeling on DailyMed
- ISRADIPINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 11 · 2026-06-17
- ISRADIPINE CAPSULE [AVKARE] · version 2 · 2026-01-15
- ISRADIPINE CAPSULE [ELITE LABORATORIES, INC.] · version 2 · 2022-12-29
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.