daunorubicin hydrochloride
- Product NDC
- 71288-182
- 11-digit product format
- 712880182
- Labeler code
- 71288
- Product ID
- 71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- daunorubicin hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA065035
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- Substance
- DAUNORUBICIN HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UD984I04LZ | DAUNORUBICIN HYDROCHLORIDE | 23541-50-6 | DAUNORUBICIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-182-05 | 71288018205 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04) | 2025-06-01 | No | No | Historical |