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 ID50242-090_2e86cc72-d755-45bd-a334-b6f4d5b07121
NDC50242-090
Product TypeHuman Prescription Drug
Proprietary NameZELBORAF
Generic NameVemurafenib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-08-17
Marketing CategoryNDA / NDA
Application NumberNDA202429
Labeler NameGenentech, Inc.
Substance NameVEMURAFENIB
Active Ingredient Strength240 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50242-090-02

1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2015-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-090-01 [50242009001]

ZELBORAF TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202429
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-08-17
Marketing End Date2018-02-28

NDC 50242-090-02 [50242009002]

ZELBORAF TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202429
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-08

NDC 50242-090-86 [50242009086]

ZELBORAF TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202429
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-10

Drug Details

Active Ingredients

IngredientStrength
VEMURAFENIB240 mg/1

OpenFDA Data

SPL SET ID:38eea320-7e0c-485a-bc30-98c3c45e2763
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1147228
  • 1147223
  • 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
    ZELBORAF
    85161615 4043246 Live/Registered
    Genentech, Inc.
    2010-10-26

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