mitomycin

Generic: mitomycin

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

Drug Facts

Product Profile

Brand Name mitomycin
Generic Name mitomycin
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mitomycin 40 mg/80mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9280
Product ID 0143-9280_643836ac-d4dc-426c-96fa-44ef273198bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064117
Listing Expiration 2026-12-31
Marketing Start 1999-09-01

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439280
Hyphenated Format 0143-9280

Supplemental Identifiers

RxCUI
1740898 1740900
UNII
50SG953SK6
NUI
N0000000236 N0000175558

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 mitomycin (source: ndc)
Generic Name mitomycin (source: ndc)
Application Number ANDA064117 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/80mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX, UNIT-DOSE (0143-9280-01) / 80 mL in 1 VIAL
source: ndc

Packages (1)

0143-9280-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9280-01) / 80 mL in 1 VIAL

Ingredients (1)

mitomycin (40 mg/80mL)

Linked Drug Pages (1)

Mitomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "643836ac-d4dc-426c-96fa-44ef273198bc", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["50SG953SK6"], "rxcui": ["1740898", "1740900"], "spl_set_id": ["5917f7a7-cd20-407b-8dda-9fd58c5f47a6"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9280-01)  / 80 mL in 1 VIAL", "package_ndc": "0143-9280-01", "marketing_start_date": "19990901"}], "brand_name": "Mitomycin", "product_id": "0143-9280_643836ac-d4dc-426c-96fa-44ef273198bc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "0143-9280", "generic_name": "Mitomycin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mitomycin", "active_ingredients": [{"name": "MITOMYCIN", "strength": "40 mg/80mL"}], "application_number": "ANDA064117", "marketing_category": "ANDA", "marketing_start_date": "19990901", "listing_expiration_date": "20261231"}