FDA Orange Book
Generic for Prostin Vr Pediatric
Prostin Vr Pediatric contains alprostadil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Prostin Vr Pediatric is alprostadil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Prostin Vr Pediatric products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.5MG/ML | Marketed (Rx) | AP | 2 | AP |
NDA 018484, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic alprostadil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 074815 | AP (A-rated, therapeutically equivalent) | January 20, 1998 | 0.5MG/ML |
| MEITHEAL PHARMACEUTICALS INC | 075196 | AP (A-rated, therapeutically equivalent) | April 30, 1999 | 0.5MG/ML |
Prostin Vr Pediatric NDC codes
Questions
Is there a generic for Prostin Vr Pediatric?
Yes. The generic name for Prostin Vr Pediatric is alprostadil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Prostin Vr Pediatric?
The active ingredient in Prostin Vr Pediatric is alprostadil, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.