Package 0078-0694-48

Brand: zykadia

Generic: ceritinib
NDC Package Sample

Package Facts

Identity

Package NDC 0078-0694-48
Digits Only 0078069448
Product NDC 0078-0694
Description

21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)

Marketing

Marketing Status
Marketed Since 2019-03-18
Brand zykadia
Generic ceritinib
Sample Package Yes

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8c405b95-6d3c-4bc5-9b01-2feb80903756", "openfda": {"nui": ["N0000175605", "N0000020001", "N0000190114", "N0000185504"], "unii": ["K418KG2GET"], "rxcui": ["2121059", "2121061"], "spl_set_id": ["fff5d805-4ffd-4e8e-8e63-6f129697563e"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)", "package_ndc": "0078-0694-48", "marketing_start_date": "20190318"}, {"sample": false, "description": "84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)", "package_ndc": "0078-0694-84", "marketing_start_date": "20190318"}], "brand_name": "ZYKADIA", "product_id": "0078-0694_8c405b95-6d3c-4bc5-9b01-2feb80903756", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "0078-0694", "generic_name": "ceritinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYKADIA", "active_ingredients": [{"name": "CERITINIB", "strength": "150 mg/1"}], "application_number": "NDA211225", "marketing_category": "NDA", "marketing_start_date": "20190318", "listing_expiration_date": "20261231"}