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NDC 00078-0682-66 Tafinlar 50 mg/1 Details
Tafinlar 50 mg/1
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.
MedlinePlus Drug Summary
Dabrafenib is used alone or in combination with trametinib (Mekinist) to treat a certain types of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body. It is also used along with trametinib to treat and prevent the return of a certain type of melanoma after surgery to remove it and any affected lymph nodes. Dabrafenib is also used in combination with trametinib to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. It is also used to treat a certain type of thyroid cancer that has spread to nearby tissues or to other parts of the body that has not responded to previous treatment(s). Dabrafenib 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 stop the spread of cancer cells.
Related Packages: 00078-0682-66Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dabrafenib
Product Information
| NDC | 00078-0682 |
|---|---|
| Product ID | 0078-0682_23689dc5-f2a5-4475-bbc1-bd73107e51ba |
| Associated GPIs | 21532025100120 |
| GCN Sequence Number | 071033 |
| GCN Sequence Number Description | dabrafenib mesylate CAPSULE 50 MG ORAL |
| HIC3 | V37 |
| HIC3 Description | ANTINEOPLASTIC - BRAF KINASE INHIBITORS |
| GCN | 34723 |
| HICL Sequence Number | 040360 |
| HICL Sequence Number Description | DABRAFENIB MESYLATE |
| Brand/Generic | Brand |
| Proprietary Name | Tafinlar |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dabrafenib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | DABRAFENIB MESYLATE |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | 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], |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA202806 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0682-66 (00078068266)
| NDC Package Code | 0078-0682-66 |
|---|---|
| Billing NDC | 00078068266 |
| Package | 120 CAPSULE in 1 BOTTLE (0078-0682-66) |
| Marketing Start Date | 2016-04-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |