mitomycin

Generic: mitomycin

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mitomycin
Generic Name mitomycin
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mitomycin 5 mg/10mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-450
Product ID 55150-450_f5a010cf-5954-4e6d-acfa-fb414efdf471
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216732
Listing Expiration 2026-12-31
Marketing Start 2023-10-30

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 55150450
Hyphenated Format 55150-450

Supplemental Identifiers

RxCUI
1740894 1740898 1740900
UPC
0355150451012
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 ANDA216732 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-450-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-450-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-450-01) / 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": "f5a010cf-5954-4e6d-acfa-fb414efdf471", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0355150451012"], "unii": ["50SG953SK6"], "rxcui": ["1740894", "1740898", "1740900"], "spl_set_id": ["f5a010cf-5954-4e6d-acfa-fb414efdf471"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-450-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-450-01", "marketing_start_date": "20231030"}], "brand_name": "MITOMYCIN", "product_id": "55150-450_f5a010cf-5954-4e6d-acfa-fb414efdf471", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "55150-450", "generic_name": "MITOMYCIN", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MITOMYCIN", "active_ingredients": [{"name": "MITOMYCIN", "strength": "5 mg/10mL"}], "application_number": "ANDA216732", "marketing_category": "ANDA", "marketing_start_date": "20231030", "listing_expiration_date": "20261231"}