mitoxantrone

Generic: mitoxantrone

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mitoxantrone
Generic Name mitoxantrone
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

mitoxantrone hydrochloride 2 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-179
Product ID 71288-179_37d2fbfc-59e6-437f-90d2-cab7b7d099f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077356
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288179
Hyphenated Format 71288-179

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 (source: ndc)
Application Number ANDA077356 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (71288-179-13) / 12.5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

71288-179-13 1 VIAL, MULTI-DOSE in 1 CARTON (71288-179-13) / 12.5 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": "37d2fbfc-59e6-437f-90d2-cab7b7d099f1", "openfda": {"unii": ["U6USW86RD0"], "rxcui": ["197989"], "spl_set_id": ["1634528a-30c5-4309-acc8-4c0293ae14ae"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-179-13)  / 12.5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "71288-179-13", "marketing_start_date": "20250601"}], "brand_name": "mitoXANTRONE", "product_id": "71288-179_37d2fbfc-59e6-437f-90d2-cab7b7d099f1", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "71288-179", "generic_name": "mitoXANTRONE", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mitoXANTRONE", "active_ingredients": [{"name": "MITOXANTRONE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA077356", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}