NDC 51991-377

IMATINIB MESYLATE

Imatinib Mesylate

IMATINIB MESYLATE is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Imatinib Mesylate.

Product ID51991-377_0f327a29-f813-4a26-bcfd-ee2021253042
NDC51991-377
Product TypeHuman Prescription Drug
Proprietary NameIMATINIB MESYLATE
Generic NameImatinib Mesylate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-02-08
Marketing CategoryANDA / ANDA
Application NumberANDA205990
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameIMATINIB MESYLATE
Active Ingredient Strength400 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51991-377-05

500 TABLET, COATED in 1 BOTTLE (51991-377-05)
Marketing Start Date2019-02-08
Marketing End Date2023-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-377-90 [51991037790]

IMATINIB MESYLATE TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-08

NDC 51991-377-33 [51991037733]

IMATINIB MESYLATE TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205990
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-08

NDC 51991-377-05 [51991037705]

IMATINIB MESYLATE TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-08

Drug Details

Active Ingredients

IngredientStrength
IMATINIB MESYLATE400 mg/1

OpenFDA Data

SPL SET ID:4d690acd-b087-4cb2-9077-fca93d779081
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403878
  • 403879
    • UPC Code
  • 0351991377900
  • 0351991376903

    • Pharmacological Class

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

    NDC Crossover Matching brand name "IMATINIB MESYLATE" or generic name "Imatinib Mesylate"

    NDCBrand NameGeneric Name
    0054-0248Imatinib MesylateImatinib Mesylate
    0054-0249Imatinib MesylateImatinib Mesylate
    0093-7629Imatinib MesylateImatinib Mesylate
    0093-7630Imatinib MesylateImatinib Mesylate
    0378-2245Imatinib Mesylateimatinib
    0378-2246Imatinib Mesylateimatinib
    0904-6621Imatinib MesylateImatinib Mesylate
    67877-634Imatinib mesylateImatinib mesylate
    67877-633Imatinib mesylateImatinib mesylate
    72485-202Imatinib mesylateImatinib mesylate
    0904-6901Imatinib MesylateImatinib Mesylate
    16714-704imatinib mesylateimatinib mesylate
    16714-705imatinib mesylateimatinib mesylate
    42292-044Imatinib MesylateImatinib Mesylate
    42292-043Imatinib MesylateImatinib Mesylate
    47335-472imatinib mesylateimatinib mesylate
    47335-475imatinib mesylateimatinib mesylate
    50268-426Imatinib MesylateImatinib Mesylate
    50268-427Imatinib MesylateImatinib Mesylate
    51991-376IMATINIB MESYLATEIMATINIB MESYLATE
    51991-377IMATINIB MESYLATEIMATINIB MESYLATE
    60429-926Imatinib MesylateImatinib Mesylate
    60505-2900Imatinib MesylateImatinib Mesylate
    60429-925Imatinib MesylateImatinib Mesylate
    60687-203Imatinib MesylateImatinib Mesylate
    60505-2901Imatinib MesylateImatinib Mesylate
    60687-192Imatinib MesylateImatinib Mesylate
    64679-794Imatinib MesylateImatinib Mesylate
    64679-793Imatinib MesylateImatinib Mesylate
    65162-795Imatinib MesylateImatinib Mesylate
    65162-794Imatinib MesylateImatinib Mesylate
    68180-390IMATINIB MESYLATEIMATINIB MESYLATE
    68180-391IMATINIB MESYLATEIMATINIB MESYLATE
    51407-270Imatinib MesylateImatinib Mesylate
    51407-269Imatinib MesylateImatinib Mesylate
    72606-556Imatinib mesylateImatinib mesylate
    72606-557Imatinib mesylateImatinib mesylate
    0078-0401Gleevecimatinib mesylate
    0078-0649Gleevecimatinib mesylate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.