mitoXANTRONE
- Product NDC
- 71288-178
- 11-digit product format
- 712880178
- Labeler code
- 71288
- Product ID
- 71288-178_37d2fbfc-59e6-437f-90d2-cab7b7d099f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mitoXANTRONE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA077356
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- Substance
- MITOXANTRONE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], 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
- mitoXANTRONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MITOXANTRONE HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U6USW86RD0 |
| Rxcui | 197989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-178-10 | mitoXANTRONE | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 1 |
| 71288-178-10 | mitoXANTRONE | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-178-10 | 71288017810 | 1 VIAL, MULTI-DOSE in 1 CARTON (71288-178-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2025-06-01 | No | No | Current |