Idarubicin Hydrochloride
- Product NDC
- 71288-184
- 11-digit product format
- 712880184
- Labeler code
- 71288
- Product ID
- 71288-184_677002b4-7b30-4d32-ae99-5ee630c5b5fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Idarubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA065036
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- Substance
- IDARUBICIN HYDROCHLORIDE
- Active strength
- 1 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Idarubicin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IDARUBICIN HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5VV3MDU5IE |
| Rxcui | 1791493, 1791498, 1791500 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-184-05 | Idarubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 71288-184-05 | Idarubicin Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-184-05 | 71288018405 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-184-05) / 5 mL in 1 VIAL, SINGLE-DOSE | 2025-06-01 | No | No | Current |