Mitoxantrone
- Product NDC
- 63323-132
- 11-digit product format
- 633230132
- Labeler code
- 63323
- Product ID
- 63323-132_0b47411d-1c42-4241-9301-4ecc3197470c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MITOXANTRONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA077496
- 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 |
|---|
| 63323-132-10 | Mitoxantrone | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 7 |
| 63323-132-10 | Mitoxantrone | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 7 |
| 63323-132-12 | Mitoxantrone | 12.5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 12.5 | | 7 |
| 63323-132-12 | Mitoxantrone | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 7 |
| 63323-132-15 | Mitoxantrone | 15 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 15 | | 7 |
| 63323-132-15 | Mitoxantrone | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 7 |
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 [FRESENIUS KABI USA, LLC] | 4 | |
| MITOXANTRONE | ACTIVE MOIETY | BZ114NVM5P | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-132 | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241019_fcb8ef8a-f770-4416-8fc5-fa01d98c8eee.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 |
|---|
| 63323-132-10 | 63323013210 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2006-04-11 | 0000-00-00 | No | No | Current |
| 63323-132-12 | 63323013212 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) / 12.5 mL in 1 VIAL, MULTI-DOSE | 2006-04-11 | 0000-00-00 | No | No | Current |
| 63323-132-15 | 63323013215 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 15 mL in 1 VIAL, MULTI-DOSE | 2006-04-11 | 0000-00-00 | No | No | Current |