Package 58468-0251-5

{"route": ["ORAL"], "spl_id": "aa3b7d8a-0e0d-481b-bd36-4befaceba422", "openfda": {"nui": ["N0000175605", "N0000193934", "N0000190114", "N0000185503", "N0000190113", "N0000190107", "N0000190108", "N0000193845"], "unii": ["NWN58M4F5T"], "rxcui": ["2722403", "2722409"], "spl_set_id": ["95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Bruton's Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Bile Salt Export Pump Inhibitors [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58468-0251-5)  / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0)", "package_ndc": "58468-0251-5", "marketing_start_date": "20250829"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58468-0251-6)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58468-0251-6", "marketing_start_date": "20250829"}], "brand_name": "WAYRILZ", "product_id": "58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422", "dosage_form": "TABLET, FILM COATED", "product_ndc": "58468-0251", "generic_name": "rilzabrutinib", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "WAYRILZ", "active_ingredients": [{"name": "RILZABRUTINIB", "strength": "400 mg/1"}], "application_number": "NDA219685", "marketing_category": "NDA", "marketing_start_date": "20250829", "listing_expiration_date": "20261231"}