mitomycin

Generic: mitomycin

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mitomycin
Generic Name mitomycin
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mitomycin 40 mg/80mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-502
Product ID 68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216648
Listing Expiration 2026-12-31
Marketing Start 2022-11-22

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 68083502
Hyphenated Format 68083-502

Supplemental Identifiers

RxCUI
1740898
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 ANDA216648 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/80mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) / 80 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-502-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) / 80 mL in 1 VIAL, SINGLE-DOSE

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": "5a0916d0-90cc-4ac2-82ba-e44138161853", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["50SG953SK6"], "rxcui": ["1740898"], "spl_set_id": ["2528999b-9f09-4e64-89fc-1e3d69c2d0b6"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01)  / 80 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-502-01", "marketing_start_date": "20221122"}], "brand_name": "MITOMYCIN", "product_id": "68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "68083-502", "generic_name": "MITOMYCIN", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MITOMYCIN", "active_ingredients": [{"name": "MITOMYCIN", "strength": "40 mg/80mL"}], "application_number": "ANDA216648", "marketing_category": "ANDA", "marketing_start_date": "20221122", "listing_expiration_date": "20261231"}