Package 0597-9257-59
Brand: hernexeos
Generic: zongertinibPackage Facts
Identity
Package NDC
0597-9257-59
Digits Only
0597925759
Product NDC
0597-9257
Description
30 CARTON in 1 BOTTLE, PLASTIC (0597-9257-59) / 1 TABLET, FILM COATED in 1 CARTON
Marketing
Marketing Status
Brand
hernexeos
Generic
zongertinib
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d63646b6-30dd-4a93-824a-5750a6150a5b", "openfda": {"nui": ["N0000175605", "N0000020008", "N0000190113"], "unii": ["DRH7R67UVL"], "spl_set_id": ["d3fabf12-354e-4e5c-b5de-20fdb579b783"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CARTON in 1 BOTTLE, PLASTIC (0597-9257-59) / 1 TABLET, FILM COATED in 1 CARTON", "package_ndc": "0597-9257-59", "marketing_start_date": "20260106"}, {"sample": false, "description": "60 CARTON in 1 BOTTLE, PLASTIC (0597-9257-86) / 1 TABLET, FILM COATED in 1 CARTON", "package_ndc": "0597-9257-86", "marketing_start_date": "20250808"}], "brand_name": "HERNEXEOS", "product_id": "0597-9257_d63646b6-30dd-4a93-824a-5750a6150a5b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "HER2/Neu/cerbB2 Antagonists [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "0597-9257", "generic_name": "zongertinib", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HERNEXEOS", "active_ingredients": [{"name": "ZONGERTINIB", "strength": "60 mg/1"}], "application_number": "NDA219042", "marketing_category": "NDA", "marketing_start_date": "20250808", "listing_expiration_date": "20271231"}