NDC 50242-090
ZELBORAF
Vemurafenib
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 |
Packaging
NDC 50242-090-02
1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2015-09-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50242-090-01 [50242009001]
ZELBORAF TABLET, FILM COATED
| 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 |
NDC 50242-090-02 [50242009002]
ZELBORAF TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202429 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-09-08 |
NDC 50242-090-86 [50242009086]
ZELBORAF TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202429 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-04-10 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| VEMURAFENIB | 240 mg/1 |
OpenFDA Data
| SPL SET ID: | 38eea320-7e0c-485a-bc30-98c3c45e2763 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Protein Kinase Inhibitors [MoA]
- Cytochrome P450 1A2 Inhibitors [MoA]
- P-Glycoprotein Inhibitors [MoA]
- Kinase Inhibitor [EPC]
- Protein Kinase Inhibitors [MoA]
- Cytochrome P450 1A2 Inhibitors [MoA]
- P-Glycoprotein Inhibitors [MoA]
Trademark Results [ZELBORAF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZELBORAF 85161615 4043246 Live/Registered |
Genentech, Inc. 2010-10-26 |
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