NDC 72485-203

Imatinib mesylate 400 mg

Imatinib Mesylate

Imatinib mesylate 400 mg is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is Imatinib Mesylate.

Product ID72485-203_2e636646-af84-4711-84b4-9092bb51ca8a
NDC72485-203
Product TypeHuman Prescription Drug
Proprietary NameImatinib mesylate 400 mg
Generic NameImatinib Mesylate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA208302
Labeler NameArmas Pharmaceuticals Inc.
Substance NameIMATINIB MESYLATE
Active Ingredient Strength400 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72485-203-30

30 TABLET, FILM COATED in 1 BOTTLE (72485-203-30)
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-203-30 [72485020330]

Imatinib mesylate 400 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208302
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
IMATINIB MESYLATE400 mg/1

OpenFDA Data

SPL SET ID:7b7cc194-29e4-4484-a364-a1ac7d7d6cf5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403879
  • UPC Code
  • 0372485203307
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Imatinib mesylate 400 mg" or generic name "Imatinib Mesylate"

    NDCBrand NameGeneric Name
    72485-203Imatinib mesylate 400 mgImatinib mesylate 400 mg
    0078-0401Gleevecimatinib mesylate
    0078-0649Gleevecimatinib mesylate
    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

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