| Product NDC: | 50242-090 | 
| Proprietary Name: | ZELBORAF | 
| Non Proprietary Name: | Vemurafenib | 
| Active Ingredient(s): | 240 mg/1 & nbsp; Vemurafenib | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, FILM COATED | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 50242-090 | 
| Labeler Name: | Genentech, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA202429 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20110817 | 
| Package NDC: | 50242-090-01 | 
| Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-01) > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 
| NDC Code | 50242-090-01 | 
| Proprietary Name | ZELBORAF | 
| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-01) > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 
| Product NDC | 50242-090 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Vemurafenib | 
| Dosage Form Name | TABLET, FILM COATED | 
| Route Name | ORAL | 
| Start Marketing Date | 20110817 | 
| Marketing Category Name | NDA | 
| Labeler Name | Genentech, Inc. | 
| Substance Name | VEMURAFENIB | 
| Strength Number | 240 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |