Active ingredient
Idarubicin
12 finished FDA listings contain Idarubicin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IDARUBICIN HYDROCHLORIDE
- Dosage forms
- Injection, Solution, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 1 mg/ml
- Brand names in FDA listings
- Idamycin Pfs
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5650
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 050734 | PFIZER | 1997-02-17 | 3 |
| ANDA 065036 | MEITHEAL | 2002-05-01 | 3 |
| ANDA 065275 | HIKMA | 2006-12-14 | 6 |
Official labeling on DailyMed
- IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] · version 27 · 2026-04-17
- IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 1 · 2025-06-02
- IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 4 · 2025-01-09
- IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 8 · 2023-04-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.