Package 59676-050-28

Brand: balversa

Generic: erdafitinib
NDC Package

Package Facts

Identity

Package NDC 59676-050-28
Digits Only 5967605028
Product NDC 59676-050
Description

1 BOTTLE in 1 CARTON (59676-050-28) / 28 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2019-04-12
Brand balversa
Generic erdafitinib
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "41ec18e6-999d-f298-e063-6294a90aa2dc", "openfda": {"nui": ["N0000175605", "N0000194026", "N0000182141", "N0000185506", "N0000185503", "N0000187061"], "unii": ["890E37NHMV"], "rxcui": ["2123131", "2123137", "2123139", "2123141", "2123143", "2123145"], "spl_set_id": ["2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Fibroblast Growth Factor Receptor Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Janssen Products LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59676-050-28)  / 28 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "59676-050-28", "marketing_start_date": "20190412"}], "brand_name": "BALVERSA", "product_id": "59676-050_41ec18e6-999d-f298-e063-6294a90aa2dc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Fibroblast Growth Factor Receptor Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Organic Cation Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "59676-050", "generic_name": "Erdafitinib", "labeler_name": "Janssen Products LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BALVERSA", "active_ingredients": [{"name": "ERDAFITINIB", "strength": "5 mg/1"}], "application_number": "NDA212018", "marketing_category": "NDA", "marketing_start_date": "20190412", "listing_expiration_date": "20261231"}