Active ingredient
Daunorubicin
6 finished FDA listings contain Daunorubicin as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- DAUNORUBICIN, DAUNORUBICIN HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 5 mg/ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3109
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 050731 | HIKMA | 1998-01-30 | 2 |
| ANDA 065035 | MEITHEAL | 2000-01-24 | 1 |
| ANDA 208759 | HISUN PHARM HANGZHOU | 2019-04-12 | 3 |
Official labeling on DailyMed
- DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] · version 13 · 2026-01-20
- DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 1 · 2025-06-02
- DAUNORUBICIN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 6 · 2024-02-16
- DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] · version 4 · 2023-02-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.