Package 0597-0137-90
Brand: gilotrif
Generic: afatinibPackage Facts
Identity
Package NDC
0597-0137-90
Digits Only
0597013790
Product NDC
0597-0137
Description
1 BOTTLE in 1 CARTON (0597-0137-90) / 30 TABLET, FILM COATED in 1 BOTTLE
Marketing
Marketing Status
Brand
gilotrif
Generic
afatinib
Sample Package
Yes
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3a365319-7ba8-4454-8239-7b0e7ff8a18e", "openfda": {"nui": ["N0000175605", "N0000175076"], "unii": ["41UD74L59M"], "rxcui": ["1430446", "1430449", "1430451", "1430453", "1430455", "1430457"], "spl_set_id": ["fd638e5e-8032-e7ca-0179-95e96ab5d387"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0597-0137-30) / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0597-0137-30", "marketing_start_date": "20130809"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (0597-0137-90) / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0597-0137-90", "marketing_end_date": "20270531", "marketing_start_date": "20181001"}], "brand_name": "Gilotrif", "product_id": "0597-0137_3a365319-7ba8-4454-8239-7b0e7ff8a18e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0597-0137", "generic_name": "afatinib", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gilotrif", "active_ingredients": [{"name": "AFATINIB", "strength": "30 mg/1"}], "application_number": "NDA201292", "marketing_category": "NDA", "marketing_start_date": "20130712", "listing_expiration_date": "20261231"}