Package 50419-395-01

Brand: nubeqa

Generic: darolutamide
NDC Package

Package Facts

Identity

Package NDC 50419-395-01
Digits Only 5041939501
Product NDC 50419-395
Product ID 50419-395_f29fbb0a-49ef-488f-b34f-1420e473e20c
Description

1 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2019-07-31
Brand nubeqa
Generic darolutamide
Sample Package No

Linked Drug Pages (1)

NUBEQA ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f29fbb0a-49ef-488f-b34f-1420e473e20c", "openfda": {"unii": ["X05U0N2RCO"], "rxcui": ["2180330", "2180336"], "spl_set_id": ["1a7cb212-56e4-4b9d-a73d-bfee7fe4735e"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50419-395-01)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50419-395-01", "marketing_start_date": "20190731"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50419-395-72)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50419-395-72", "marketing_start_date": "20210303"}], "brand_name": "NUBEQA", "product_id": "50419-395_f29fbb0a-49ef-488f-b34f-1420e473e20c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50419-395", "generic_name": "darolutamide", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NUBEQA", "active_ingredients": [{"name": "DAROLUTAMIDE", "strength": "300 mg/1"}], "application_number": "NDA212099", "marketing_category": "NDA", "marketing_start_date": "20190731", "listing_expiration_date": "20271231"}