FDA Orange Book
Generic for Idamycin PFS
Idamycin PFS contains idarubicin. 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 Idamycin PFS is idarubicin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Idamycin PFS products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 5MG/5ML (1MG/ML) | Marketed (Rx) | AP | 3 | AP |
NDA 050734, 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 idarubicin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MEITHEAL PHARMACEUTICALS INC | 065036 | AP (A-rated, therapeutically equivalent) | May 1, 2002 | 5MG/5ML (1MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 065275 | AP (A-rated, therapeutically equivalent) | December 14, 2006 | 5MG/5ML (1MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 065288 | AP (A-rated, therapeutically equivalent) | May 15, 2007 | 5MG/5ML (1MG/ML) |
Idamycin PFS NDC codes
Questions
Is there a generic for Idamycin PFS?
Yes. The generic name for Idamycin PFS is idarubicin. 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 Idamycin PFS?
The active ingredient in Idamycin PFS is idarubicin, 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.