mitoxantrone

Generic: mitoxantrone hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mitoxantrone
Generic Name mitoxantrone hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mitoxantrone hydrochloride 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-132
Product ID 63323-132_0b47411d-1c42-4241-9301-4ecc3197470c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077496
Listing Expiration 2026-12-31
Marketing Start 2006-04-11

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323132
Hyphenated Format 63323-132

Supplemental Identifiers

RxCUI
197989
UNII
U6USW86RD0

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mitoxantrone (source: ndc)
Generic Name mitoxantrone hydrochloride (source: ndc)
Application Number ANDA077496 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) / 10 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) / 12.5 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 15 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (3)

63323-132-10 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) / 10 mL in 1 VIAL, MULTI-DOSE 63323-132-12 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) / 12.5 mL in 1 VIAL, MULTI-DOSE 63323-132-15 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 15 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

mitoxantrone hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Mitoxantrone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0b47411d-1c42-4241-9301-4ecc3197470c", "openfda": {"unii": ["U6USW86RD0"], "rxcui": ["197989"], "spl_set_id": ["fcb8ef8a-f770-4416-8fc5-fa01d98c8eee"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-132-10", "marketing_start_date": "20060411"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12)  / 12.5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-132-12", "marketing_start_date": "20060411"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15)  / 15 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-132-15", "marketing_start_date": "20060411"}], "brand_name": "Mitoxantrone", "product_id": "63323-132_0b47411d-1c42-4241-9301-4ecc3197470c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "63323-132", "generic_name": "MITOXANTRONE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mitoxantrone", "active_ingredients": [{"name": "MITOXANTRONE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA077496", "marketing_category": "ANDA", "marketing_start_date": "20060411", "listing_expiration_date": "20261231"}