NDC 0078-0401

Gleevec

Imatinib Mesylate

Gleevec is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Imatinib Mesylate.

Product ID0078-0401_1077cda3-a7c8-482d-b8c6-a87007bbfbac
NDC0078-0401
Product TypeHuman Prescription Drug
Proprietary NameGleevec
Generic NameImatinib Mesylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-05-15
Marketing CategoryNDA / NDA
Application NumberNDA021588
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameIMATINIB MESYLATE
Active Ingredient Strength100 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0401-34

90 TABLET in 1 BOTTLE (0078-0401-34)
Marketing Start Date2001-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0401-34 [00078040134]

Gleevec TABLET
Marketing CategoryNDA
Application NumberNDA021588
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-05-15

Drug Details

Active Ingredients

IngredientStrength
IMATINIB MESYLATE100 mg/1

OpenFDA Data

SPL SET ID:211ef2da-2868-4a77-8055-1cb2cd78e24b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 404589
  • 404588
  • 403878
  • 403879
  • UPC Code
  • 0300780401340
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Gleevec" or generic name "Imatinib Mesylate"

    NDCBrand NameGeneric Name
    0078-0401Gleevecimatinib mesylate
    0078-0649Gleevecimatinib mesylate
    66828-0030GleevecGleevec
    0054-0248Imatinib MesylateImatinib Mesylate
    0054-0249Imatinib MesylateImatinib Mesylate
    0093-7629Imatinib MesylateImatinib Mesylate
    0093-7630Imatinib MesylateImatinib Mesylate
    0904-6621Imatinib MesylateImatinib Mesylate
    0904-6901Imatinib MesylateImatinib Mesylate
    16714-704imatinib mesylateimatinib mesylate

    Trademark Results [Gleevec]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLEEVEC
    GLEEVEC
    78478393 3238831 Live/Registered
    Novartis AG
    2004-09-03
    GLEEVEC
    GLEEVEC
    78056665 2675047 Live/Registered
    Novartis AG
    2001-04-04

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.