NDC 0078-0716

TABRECTA

Capmatinib

TABRECTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Capmatinib.

• Product ID: 0078-0716_09072608-375f-4c64-b09a-8fc453868473
• NDC: 0078-0716
• Product Type: Human Prescription Drug
• Proprietary Name: TABRECTA
• Generic Name: Capmatinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-05-06
• Marketing Category: NDA / NDA
• Application Number: NDA213591
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: CAPMATINIB
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0078-0716-56

56 TABLET, FILM COATED in 1 BOTTLE (0078-0716-56)

• Marketing Start Date: 2020-05-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0716-94 [00078071694]

TABRECTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA213591
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-06

NDC 0078-0716-56 [00078071656]

TABRECTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA213591
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-06

Drug Details

Active Ingredients

Ingredient	Strength
CAPMATINIB	200 mg/1

NDC Crossover Matching brand name "TABRECTA" or generic name "Capmatinib"

NDC	Brand Name	Generic Name
0078-0709	TABRECTA	capmatinib
0078-0716	TABRECTA	capmatinib