Mitoxantrone
- Product NDC
- 61703-343
- 11-digit product format
- 617030343
- Labeler code
- 61703
- Product ID
- 61703-343_8658f2e1-ad36-4ce0-af12-80814bd8bf5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitoxantrone
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA076871
- Marketing category
- ANDA
- Marketing start
- 2006-04-11
- 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 |
|---|
| 61703-343-18 | Mitoxantrone | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 25 |
| 61703-343-18 | Mitoxantrone | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 25 |
| 61703-343-65 | Mitoxantrone | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 25 |
| 61703-343-65 | Mitoxantrone | 12.5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 12.5 | | 25 |
| 61703-343-66 | Mitoxantrone | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 25 |
| 61703-343-66 | Mitoxantrone | 15 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 15 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MITOXANTRONE HYDROCHLORIDE | ACTIVE INGREDIENT | U6USW86RD0 | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.] | 16 | |
| MITOXANTRONE | ACTIVE MOIETY | BZ114NVM5P | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.] | 16 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.] | 16 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.] | 16 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.] | 16 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61703-343 | MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] | 24 | Current NDC, Legacy NDC, 6 package rows | 20250121_accf9569-4b57-4e83-a7db-4e890a75d1ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61703-343-18 | 61703034318 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) / 10 mL in 1 VIAL, MULTI-DOSE | 2006-04-11 | 0000-00-00 | No | No | Current |
| 61703-343-65 | 61703034365 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) / 12.5 mL in 1 VIAL, MULTI-DOSE | 2006-04-11 | 0000-00-00 | No | No | Current |
| 61703-343-66 | 61703034366 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66) / 15 mL in 1 VIAL, MULTI-DOSE | 2006-04-11 | 0000-00-00 | No | No | Current |