NDC 0078-0681

Tafinlar

Dabrafenib

Tafinlar is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Dabrafenib Mesylate.

• Product ID: 0078-0681_058c0b15-6711-4cf3-9c07-6892bad16e38
• NDC: 0078-0681
• Product Type: Human Prescription Drug
• Proprietary Name: Tafinlar
• Generic Name: Dabrafenib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-01
• Marketing Category: NDA / NDA
• Application Number: NDA202806
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: DABRAFENIB MESYLATE
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0681-66

120 CAPSULE in 1 BOTTLE (0078-0681-66)

• Marketing Start Date: 2016-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0681-66 [00078068166]

Tafinlar CAPSULE

• Marketing Category: NDA
• Application Number: NDA202806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-01

Drug Details

Active Ingredients

Ingredient	Strength
DABRAFENIB MESYLATE	75 mg/1

OpenFDA Data

• SPL SET ID: fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • B6DC89I63E
• RxNorm Concept Unique ID - RxCUI:
  • 1425230
  • 1424918
  • 1425228
  • 1424916

Pharmacological Class

• Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
• Organic Anion Transporter 1 Inhibitors [MoA]
• Organic Anion Transporter 3 Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2C8 Inducers [MoA]
• Cytochrome P450 2C9 Inducers [MoA]
• Cytochrome P450 2C19 Inducers [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]

NDC Crossover Matching brand name "Tafinlar" or generic name "Dabrafenib"

NDC	Brand Name	Generic Name
0078-0681	Tafinlar	dabrafenib
0078-0682	Tafinlar	dabrafenib