Package 0078-1154-21

Brand: tafinlar

Generic: dabrafenib
NDC Package

Package Facts

Identity

Package NDC 0078-1154-21
Digits Only 0078115421
Product NDC 0078-1154
Description

210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)

Marketing

Marketing Status
Marketed Since 2023-03-16
Brand tafinlar
Generic dabrafenib
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "27e1701b-e920-49fc-a56f-46b2d23a8271", "openfda": {"unii": ["B6DC89I63E"], "rxcui": ["1424916", "1424918", "1425228", "1425230", "2632552", "2632556"], "spl_set_id": ["fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)", "package_ndc": "0078-1154-21", "marketing_start_date": "20230316"}], "brand_name": "Tafinlar", "product_id": "0078-1154_27e1701b-e920-49fc-a56f-46b2d23a8271", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Kinase Inhibitor [EPC]", "Organic Anion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0078-1154", "generic_name": "dabrafenib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tafinlar", "active_ingredients": [{"name": "DABRAFENIB MESYLATE", "strength": "10 mg/1"}], "application_number": "NDA217514", "marketing_category": "NDA", "marketing_start_date": "20230316", "listing_expiration_date": "20261231"}