Package 68083-483-01

Brand: mitomycin

Generic: mitomycin
NDC Package

Package Facts

Identity

Package NDC 68083-483-01
Digits Only 6808348301
Product NDC 68083-483
Product ID 68083-483_64496224-9cec-48bb-a750-db192dd7780c
Description

1 VIAL in 1 CARTON (68083-483-01) / 10 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2021-10-20
Brand mitomycin
Generic mitomycin
Sample Package No

Linked Drug Pages (1)

MITOMYCIN ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "64496224-9cec-48bb-a750-db192dd7780c", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["50SG953SK6"], "rxcui": ["1740894", "1740900"], "spl_set_id": ["650d3024-b9a9-4018-8115-0951acfe3145"], "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 in 1 CARTON (68083-483-01)  / 10 mL in 1 VIAL", "package_ndc": "68083-483-01", "marketing_start_date": "20211020"}], "brand_name": "MITOMYCIN", "product_id": "68083-483_64496224-9cec-48bb-a750-db192dd7780c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "68083-483", "generic_name": "MITOMYCIN", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MITOMYCIN", "active_ingredients": [{"name": "MITOMYCIN", "strength": "5 mg/10mL"}], "application_number": "ANDA215687", "marketing_category": "ANDA", "marketing_start_date": "20211020", "listing_expiration_date": "20261231"}