Active ingredient
Epoprostenol
8 finished FDA listings contain Epoprostenol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EPOPROSTENOL, EPOPROSTENOL SODIUM
- Dosage forms
- Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- .5 mg/10ml · 1.5 mg/10ml
- Brand names in FDA listings
- Veletri
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8814
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 022260 | ACTELION | 2008-06-27 | 2 |
| ANDA 210473 | SUN PHARM | 2021-01-15 | 2 |
| ANDA 213913 | MYLAN | 2024-06-12 | 2 |
| ANDA 219237 | GLAND | 2025-12-29 | 2 |
Official labeling on DailyMed
- EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] · version 5 · 2026-01-07
- EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2025-04-25
- EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] · version 1 · 2024-10-04
- VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] · version 15 · 2022-11-30
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.