Active ingredient
Dipyridamole
16 finished FDA listings contain Dipyridamole as their only active ingredient; 9 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- DIPYRIDAMOLE
- Dosage forms
- Injection, Tablet, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 25 mg/1 · 5 mg/ml · 50 mg/1 · 75 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3521
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 074521 | HIKMA | 1996-10-18 | 3 |
| ANDA 040542 | OXFORD PHARMS | 2006-04-21 | 3 |
| ANDA 040782 | IMPAX LABS | 2007-07-18 | 3 |
| ANDA 040874 | ZYDUS PHARMS USA INC | 2008-01-28 | 7 |
Official labeling on DailyMed
- DIPYRIDAMOLE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 9 · 2026-08-11
- DIPYRIDAMOLE TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-04-30
- DIPYRIDAMOLE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 8 · 2026-04-29
- DIPYRIDAMOLE INJECTION [HENRY SCHEIN, INC.] · version 5 · 2025-11-17
- DIPYRIDAMOLE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 3 · 2025-01-10
- DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] · version 8 · 2024-12-02
- DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 10 · 2023-09-18
- DIPYRIDAMOLE TABLET, FILM COATED [OXFORD PHARMACEUTICALS, LLC] · version 1 · 2021-04-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.