Package 80725-620-25

Brand: myleran

Generic: busulfan
NDC Package

Package Facts

Identity

Package NDC 80725-620-25
Digits Only 8072562025
Product NDC 80725-620
Description

25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)

Marketing

Marketing Status
Marketed Since 2023-05-15
Brand myleran
Generic busulfan
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "da6a0ae8-6165-4e4f-b759-600cd940d252", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["105551", "197422"], "spl_set_id": ["2da33e5b-dcfb-4cdf-b163-50398e42f41c"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)", "package_ndc": "80725-620-25", "marketing_start_date": "20230515"}], "brand_name": "MYLERAN", "product_id": "80725-620_da6a0ae8-6165-4e4f-b759-600cd940d252", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "80725-620", "generic_name": "busulfan", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MYLERAN", "active_ingredients": [{"name": "BUSULFAN", "strength": "2 mg/1"}], "application_number": "NDA009386", "marketing_category": "NDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}