mitoxantrone

Generic: mitoxantrone

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mitoxantrone hydrochloride 2 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 61703-343
Product ID 61703-343_8658f2e1-ad36-4ce0-af12-80814bd8bf5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076871
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 61703343
Hyphenated Format 61703-343

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 ANDA076871 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) / 10 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) / 12.5 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66) / 15 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (3)

61703-343-18 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) / 10 mL in 1 VIAL, MULTI-DOSE 61703-343-65 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) / 12.5 mL in 1 VIAL, MULTI-DOSE 61703-343-66 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66) / 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": "8658f2e1-ad36-4ce0-af12-80814bd8bf5c", "openfda": {"unii": ["U6USW86RD0"], "rxcui": ["197989"], "spl_set_id": ["accf9569-4b57-4e83-a7db-4e890a75d1ba"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "61703-343-18", "marketing_start_date": "20060411"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65)  / 12.5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "61703-343-65", "marketing_start_date": "20060411"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66)  / 15 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "61703-343-66", "marketing_start_date": "20060411"}], "brand_name": "Mitoxantrone", "product_id": "61703-343_8658f2e1-ad36-4ce0-af12-80814bd8bf5c", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "61703-343", "generic_name": "Mitoxantrone", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mitoxantrone", "active_ingredients": [{"name": "MITOXANTRONE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA076871", "marketing_category": "ANDA", "marketing_start_date": "20060411", "listing_expiration_date": "20261231"}