NDC 0078-0668

Mekinist

Trametinib

Mekinist is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Trametinib Dimethyl Sulfoxide.

Product ID0078-0668_0a830197-c5c0-4299-a669-2abf0ea11c6a
NDC0078-0668
Product TypeHuman Prescription Drug
Proprietary NameMekinist
Generic NameTrametinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-17
Marketing CategoryNDA / NDA
Application NumberNDA204114
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameTRAMETINIB DIMETHYL SULFOXIDE
Active Ingredient Strength2 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0668-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0668-15)
Marketing Start Date2016-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0668-15 [00078066815]

Mekinist TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204114
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-17

Drug Details

Active Ingredients

IngredientStrength
TRAMETINIB DIMETHYL SULFOXIDE2 mg/1

OpenFDA Data

SPL SET ID:0002ad27-779d-42ab-83b5-bc65453412a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1425118
  • 1425104
  • 1425116
  • 1425110
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Mekinist" or generic name "Trametinib"

    NDCBrand NameGeneric Name
    0078-0666Mekinisttrametinib
    0078-0668Mekinisttrametinib
    0078-1105Mekinisttrametinib
    0078-1112Mekinisttrametinib

    Trademark Results [Mekinist]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MEKINIST
    MEKINIST
    85399275 4448207 Live/Registered
    NOVARTIS PHARMA AG
    2011-08-16

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