Package 65219-568-00

Brand: mitomycin

Generic: mitomycin
NDC Package

Package Facts

Identity

Package NDC 65219-568-00
Digits Only 6521956800
Product NDC 65219-568
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00) / 80 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2023-01-15
Brand mitomycin
Generic mitomycin
Sample Package No

Linked Drug Pages (0)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "c8893d3b-e9e0-4ab1-8c6d-376a7f1037bc", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["50SG953SK6"], "rxcui": ["1740898"], "spl_set_id": ["bc937e3d-7167-49a5-b6b1-004b0f89d8c4"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00)  / 80 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65219-568-00", "marketing_start_date": "20230115"}], "brand_name": "MITOMYCIN", "product_id": "65219-568_c8893d3b-e9e0-4ab1-8c6d-376a7f1037bc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "65219-568", "generic_name": "MITOMYCIN", "labeler_name": "Fresenius Kabi USA, LLC", "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": "20230115", "listing_expiration_date": "20261231"}