tafinlar

Generic: dabrafenib

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

Drug Facts

Product Profile

Brand Name tafinlar
Generic Name dabrafenib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

dabrafenib mesylate 10 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1154
Product ID 0078-1154_27e1701b-e920-49fc-a56f-46b2d23a8271
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217514
Listing Expiration 2026-12-31
Marketing Start 2023-03-16

Pharmacologic Class

Classes
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] organic anion transporter 1 inhibitors [moa] organic anion transporter 3 inhibitors [moa] organic anion transporting polypeptide 1b1 inhibitors [moa] organic anion transporting polypeptide 1b3 inhibitors [moa] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781154
Hyphenated Format 0078-1154

Supplemental Identifiers

RxCUI
1424916 1424918 1425228 1425230 2632552 2632556
UNII
B6DC89I63E

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 tafinlar (source: ndc)
Generic Name dabrafenib (source: ndc)
Application Number NDA217514 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)
source: ndc

Packages (1)

0078-1154-21 210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)

Ingredients (1)

dabrafenib mesylate (10 mg/1)

Linked Drug Pages (1)

Tafinlar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27e1701b-e920-49fc-a56f-46b2d23a8271", "openfda": {"unii": ["B6DC89I63E"], "rxcui": ["1424916", "1424918", "1425228", "1425230", "2632552", "2632556"], "spl_set_id": ["fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)", "package_ndc": "0078-1154-21", "marketing_start_date": "20230316"}], "brand_name": "Tafinlar", "product_id": "0078-1154_27e1701b-e920-49fc-a56f-46b2d23a8271", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_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]", "Organic Anion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0078-1154", "generic_name": "dabrafenib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tafinlar", "active_ingredients": [{"name": "DABRAFENIB MESYLATE", "strength": "10 mg/1"}], "application_number": "NDA217514", "marketing_category": "NDA", "marketing_start_date": "20230316", "listing_expiration_date": "20261231"}