mitomycin

Generic: mitomycin

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

Drug Facts

Product Profile

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

mitomycin 5 mg/10mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-137
Product ID 71288-137_a78f4900-61e4-4e22-bfcb-6b5210c94c57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214505
Listing Expiration 2026-12-31
Marketing Start 2022-09-08

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 71288137
Hyphenated Format 71288-137

Supplemental Identifiers

RxCUI
1740894 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 ANDA214505 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-137-20) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-137-20 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-137-20) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

mitomycin (5 mg/10mL)

Linked Drug Pages (1)

MITOMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a78f4900-61e4-4e22-bfcb-6b5210c94c57", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["50SG953SK6"], "rxcui": ["1740894", "1740900"], "spl_set_id": ["9dd0e3f2-0938-4c57-8d09-040b5405b44f"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-137-20)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-137-20", "marketing_start_date": "20220908"}], "brand_name": "MITOMYCIN", "product_id": "71288-137_a78f4900-61e4-4e22-bfcb-6b5210c94c57", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "71288-137", "generic_name": "MITOMYCIN", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MITOMYCIN", "active_ingredients": [{"name": "MITOMYCIN", "strength": "5 mg/10mL"}], "application_number": "ANDA214505", "marketing_category": "ANDA", "marketing_start_date": "20220908", "listing_expiration_date": "20261231"}