Package 57894-080-90
Brand: lazcluze
Generic: lazertinibPackage Facts
Identity
Package NDC
57894-080-90
Digits Only
5789408090
Product NDC
57894-080
Description
1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE
Marketing
Marketing Status
Brand
lazcluze
Generic
lazertinib
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2a2d3969-bab8-4a8a-992d-439e62867974", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000182141", "N0000190113"], "unii": ["4A2Y23XK11"], "rxcui": ["2691156", "2691162", "2691164", "2691166"], "spl_set_id": ["c417f9ee-2027-4ed5-92ad-3c19266de16c"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57894-080-60", "marketing_start_date": "20240820"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57894-080-90", "marketing_start_date": "20240820"}], "brand_name": "LAZCLUZE", "product_id": "57894-080_2a2d3969-bab8-4a8a-992d-439e62867974", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "57894-080", "generic_name": "lazertinib", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAZCLUZE", "active_ingredients": [{"name": "LAZERTINIB", "strength": "80 mg/1"}], "application_number": "NDA219008", "marketing_category": "NDA", "marketing_start_date": "20240820", "listing_expiration_date": "20261231"}