doxorubicin hydrochloride
- Product NDC
- 46708-810
- 11-digit product format
- 467080810
- Labeler code
- 46708
- Product ID
- 46708-810_f8e001f5-441c-47cd-86f6-5d5e3de16bc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxorubicin hydrochloride
- Dosage form
- INJECTION, SUSPENSION, LIPOSOMAL
- Route
- INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA219199
- Marketing category
- ANDA
- Marketing start
- 2025-06-27
- Substance
- DOXORUBICIN HYDROCHLORIDE
- Active strength
- 2 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
- doxorubicin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXORUBICIN HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82F2G7BL4E |
| Rxcui | 1790115, 1790127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-810-10 | doxorubicin hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION, LIPOSOMAL | 10 | | 1 |
| 46708-810-10 | doxorubicin hydrochloride | 1 in 1 CARTON | INJECTION, SUSPENSION, LIPOSOMAL | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-810-10 | 46708081010 | 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-810-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-06-27 | No | No | Current |