Package 50419-489-01

Brand: nexavar

Generic: sorafenib
NDC Package

Package Facts

Identity

Package NDC 50419-489-01
Digits Only 5041948901
Product NDC 50419-489
Description

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)

Marketing

Marketing Status
Marketed Since 2023-10-02
Brand nexavar
Generic sorafenib
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "e597a26e-e04a-4f91-8c7c-a83243286396", "openfda": {"nui": ["N0000175605", "N0000175076"], "unii": ["9ZOQ3TZI87"], "rxcui": ["597747", "615979"], "spl_set_id": ["b50667e4-5ebc-4968-a646-d605058dbef0"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)", "package_ndc": "50419-489-01", "marketing_start_date": "20231002"}], "brand_name": "Nexavar", "product_id": "50419-489_e597a26e-e04a-4f91-8c7c-a83243286396", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "50419-489", "generic_name": "sorafenib", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexavar", "active_ingredients": [{"name": "SORAFENIB", "strength": "200 mg/1"}], "application_number": "NDA021923", "marketing_category": "NDA", "marketing_start_date": "20231002", "listing_expiration_date": "20261231"}