Package 68083-502-01
Brand: mitomycin
Generic: mitomycinPackage Facts
Identity
Package NDC
68083-502-01
Digits Only
6808350201
Product NDC
68083-502
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) / 80 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
mitomycin
Generic
mitomycin
Sample Package
No
Linked Drug Pages (1)
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"}