Active ingredient
Alprostadil
10 finished FDA listings contain Alprostadil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALPROSTADIL
- Dosage forms
- Injection, Powder, Lyophilized, For Solution, Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intracavernous, Intravascular, Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 10 ug/.5ml · 10 ug/ml · 20 ug/.5ml · 20 ug/ml · 20.5 ug/ml · 40 ug/ml · 41.1 ug/ml · 500 ug/ml
- Brand names in FDA listings
- Caverject, Caverject Impulse, Edex, Prostin Vr Pediatric
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 598
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 018484 | PFIZER | 1981-10-16 | 2 |
| NDA 020379 | PFIZER | 1995-07-06 | 2 |
| NDA 020649 | ENDO OPERATIONS | 1997-06-12 | 3 |
| ANDA 075196 | MEITHEAL | 1999-04-30 | 1 |
| NDA 021212 | PFIZER | 2002-06-11 | 2 |
Official labeling on DailyMed
- PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] · version 4 · 2026-08-25
- PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] · version 12 · 2026-08-25
- EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] · version 17 · 2026-07-13
- ALPROSTADIL INJECTION, SOLUTION, CONCENTRATE [MEITHEAL PHARMACEUTICALS INC.] · version 1 · 2024-09-16
- CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] · version 19 · 2024-05-17
- CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] · version 16 · 2024-03-04
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.