"0078-1154-21" National Drug Code (NDC)

NDC Code	0078-1154-21
Package Description	210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)
Product NDC	0078-1154
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Tafinlar
Non-Proprietary Name	Dabrafenib
Dosage Form	TABLET, FOR SUSPENSION
Usage	ORAL
Start Marketing Date	20230316
Marketing Category Name	NDA
Application Number	NDA217514
Manufacturer	Novartis Pharmaceuticals Corporation
Substance Name	DABRAFENIB MESYLATE
Strength	10
Strength Unit	mg/1
Pharmacy Classes	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]