Package 69448-003-38

Brand: mutamycin

Generic: mitomycin
NDC Package

Package Facts

Identity

Package NDC 69448-003-38
Digits Only 6944800338
Product NDC 69448-003
Description

1 VIAL in 1 BOX, UNIT-DOSE (69448-003-38) / 80 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2017-07-25
Brand mutamycin
Generic mitomycin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "302614d9-cc10-737a-e063-6294a90a41c3", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0369448001056", "0369448002114"], "unii": ["50SG953SK6"], "rxcui": ["1740894", "1740898", "1740900", "1812480", "1812482", "1812484"], "spl_set_id": ["cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Accord BioPharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (69448-003-38)  / 80 mL in 1 VIAL", "package_ndc": "69448-003-38", "marketing_start_date": "20170725"}], "brand_name": "MUTAMYCIN", "product_id": "69448-003_302614d9-cc10-737a-e063-6294a90a41c3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "69448-003", "generic_name": "Mitomycin", "labeler_name": "Accord BioPharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MUTAMYCIN", "active_ingredients": [{"name": "MITOMYCIN", "strength": "40 mg/80mL"}], "application_number": "ANDA064144", "marketing_category": "ANDA", "marketing_start_date": "20170725", "listing_expiration_date": "20261231"}