ZELBORAF is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Vemurafenib.
Product ID | 50242-090_2e86cc72-d755-45bd-a334-b6f4d5b07121 |
NDC | 50242-090 |
Product Type | Human Prescription Drug |
Proprietary Name | ZELBORAF |
Generic Name | Vemurafenib |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2011-08-17 |
Marketing Category | NDA / NDA |
Application Number | NDA202429 |
Labeler Name | Genentech, Inc. |
Substance Name | VEMURAFENIB |
Active Ingredient Strength | 240 mg/1 |
Pharm Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2015-09-08 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA202429 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2011-08-17 |
Marketing End Date | 2018-02-28 |
Marketing Category | NDA |
Application Number | NDA202429 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2015-09-08 |
Marketing Category | NDA |
Application Number | NDA202429 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2014-04-10 |
Ingredient | Strength |
---|---|
VEMURAFENIB | 240 mg/1 |
SPL SET ID: | 38eea320-7e0c-485a-bc30-98c3c45e2763 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZELBORAF 85161615 4043246 Live/Registered |
Genentech, Inc. 2010-10-26 |