Package 50419-171-00

Brand: stivarga

Generic: regorafenib
NDC Package

Package Facts

Identity

Package NDC 50419-171-00
Digits Only 5041917100
Product NDC 50419-171
Description

210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2012-09-27
Brand stivarga
Generic regorafenib
Sample Package No

Linked Drug Pages (0)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8f47fb28-9855-4482-b807-e98c425c2a4e", "openfda": {"unii": ["MGN125FS9D"], "rxcui": ["1312402", "1312408"], "spl_set_id": ["824f19c9-0546-4a8a-8d8f-c4055c04f7c7"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "210 BOTTLE in 1 BOX (50419-171-00)  / 28 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50419-171-00", "marketing_start_date": "20120927"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (50419-171-03)  / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)", "package_ndc": "50419-171-03", "marketing_start_date": "20120927"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50419-171-04)  / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50419-171-04", "marketing_start_date": "20120927"}, {"sample": false, "description": "4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06)  / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05)", "package_ndc": "50419-171-06", "marketing_start_date": "20210501"}], "brand_name": "Stivarga", "product_id": "50419-171_8f47fb28-9855-4482-b807-e98c425c2a4e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]", "UGT1A1 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]"], "product_ndc": "50419-171", "generic_name": "regorafenib", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Stivarga", "active_ingredients": [{"name": "REGORAFENIB", "strength": "40 mg/1"}], "application_number": "NDA203085", "marketing_category": "NDA", "marketing_start_date": "20120927", "listing_expiration_date": "20271231"}