Search by Drug Name or NDC
NDC 00078-0716-56 TABRECTA 200 mg/1 Details
TABRECTA 200 mg/1
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 HYDROCHLORIDE.
MedlinePlus Drug Summary
Capmatinib is used to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Capmatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
Related Packages: 00078-0716-56Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Capmatinib
Product Information
| NDC | 00078-0716 |
|---|---|
| Product ID | 0078-0716_761d7399-fb73-455a-88de-c6ec4f13ba2c |
| Associated GPIs | 21533716200330 |
| GCN Sequence Number | 081015 |
| GCN Sequence Number Description | capmatinib hydrochloride TABLET 200 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 48013 |
| HICL Sequence Number | 046519 |
| HICL Sequence Number Description | CAPMATINIB HYDROCHLORIDE |
| Brand/Generic | Brand |
| Proprietary Name | TABRECTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | capmatinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | CAPMATINIB HYDROCHLORIDE |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical 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 Extrusio |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213591 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00078-0716-56 (00078071656)
| NDC Package Code | 0078-0716-56 |
|---|---|
| Billing NDC | 00078071656 |
| Package | 56 TABLET, FILM COATED in 1 BOTTLE (0078-0716-56) |
| Marketing Start Date | 2020-05-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |