Package 0078-0709-94

Brand: tabrecta

Generic: capmatinib
NDC Package Sample

Package Facts

Identity

Package NDC 0078-0709-94
Digits Only 0078070994
Product NDC 0078-0709
Description

56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)

Marketing

Marketing Status
Marketed Since 2020-05-06
Brand tabrecta
Generic capmatinib
Sample Package Yes

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "0df064bb-358d-4c21-8525-9b8b9a5845a1", "openfda": {"unii": ["C2A374O70X"], "rxcui": ["2362234", "2362240", "2362242", "2362244"], "spl_set_id": ["455892c3-d144-4ba8-9ab4-79cabff9876d"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56)", "package_ndc": "0078-0709-56", "marketing_start_date": "20200506"}, {"sample": true, "description": "56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)", "package_ndc": "0078-0709-94", "marketing_start_date": "20200506"}], "brand_name": "TABRECTA", "product_id": "0078-0709_0df064bb-358d-4c21-8525-9b8b9a5845a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Mesenchymal Epithelial Transition Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0078-0709", "generic_name": "capmatinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TABRECTA", "active_ingredients": [{"name": "CAPMATINIB HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "NDA213591", "marketing_category": "NDA", "marketing_start_date": "20200506", "listing_expiration_date": "20261231"}