tabrecta

Generic: capmatinib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tabrecta
Generic Name capmatinib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

capmatinib hydrochloride 150 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0709
Product ID 0078-0709_0df064bb-358d-4c21-8525-9b8b9a5845a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213591
Listing Expiration 2026-12-31
Marketing Start 2020-05-06

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780709
Hyphenated Format 0078-0709

Supplemental Identifiers

RxCUI
2362234 2362240 2362242 2362244
UNII
C2A374O70X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tabrecta (source: ndc)
Generic Name capmatinib (source: ndc)
Application Number NDA213591 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56)
  • 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)
source: ndc

Packages (2)

0078-0709-56 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56) 0078-0709-94 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)

Ingredients (1)

capmatinib hydrochloride (150 mg/1)

Linked Drug Pages (1)

TABRECTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0df064bb-358d-4c21-8525-9b8b9a5845a1", "openfda": {"unii": ["C2A374O70X"], "rxcui": ["2362234", "2362240", "2362242", "2362244"], "spl_set_id": ["455892c3-d144-4ba8-9ab4-79cabff9876d"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56)", "package_ndc": "0078-0709-56", "marketing_start_date": "20200506"}, {"sample": true, "description": "56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)", "package_ndc": "0078-0709-94", "marketing_start_date": "20200506"}], "brand_name": "TABRECTA", "product_id": "0078-0709_0df064bb-358d-4c21-8525-9b8b9a5845a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "0078-0709", "generic_name": "capmatinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TABRECTA", "active_ingredients": [{"name": "CAPMATINIB HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "NDA213591", "marketing_category": "NDA", "marketing_start_date": "20200506", "listing_expiration_date": "20261231"}