NDC 50242-717

Cotellic

Cobimetinib

Cotellic is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Cobimetinib Fumarate.

Product ID50242-717_29fb8757-a2d6-48d4-aa11-752d0ea8d5e2
NDC50242-717
Product TypeHuman Prescription Drug
Proprietary NameCotellic
Generic NameCobimetinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-11-10
Marketing CategoryNDA / NDA
Application NumberNDA206192
Labeler NameGenentech, Inc.
Substance NameCOBIMETINIB FUMARATE
Active Ingredient Strength20 mg/1
Pharm ClassesKinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50242-717-01

63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)
Marketing Start Date2015-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-717-01 [50242071701]

Cotellic TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206192
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-10

NDC 50242-717-86 [50242071786]

Cotellic TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-10

Drug Details

Active Ingredients

IngredientStrength
COBIMETINIB FUMARATE20 mg/1

OpenFDA Data

SPL SET ID:c387579e-cee0-4334-bd1e-73f93ac1bde6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1722376
  • 1722370
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Kinase Inhibitors [MoA]

    Trademark Results [Cotellic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COTELLIC
    COTELLIC
    86305545 4914506 Live/Registered
    GENENTECH, INC.
    2014-06-10

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