NDC 0378-2245

Imatinib Mesylate

Imatinib

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

Product ID0378-2245_012fca57-d8e1-46dc-bfff-a3184f4de599
NDC0378-2245
Product TypeHuman Prescription Drug
Proprietary NameImatinib Mesylate
Generic NameImatinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-09-28
Marketing CategoryANDA / ANDA
Application NumberANDA204644
Labeler NameMylan Pharmaceuticals Inc.
Substance NameIMATINIB MESYLATE
Active Ingredient Strength100 mg/1
Pharm ClassesBcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-2245-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77)
Marketing Start Date2017-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2245-77 [00378224577]

Imatinib Mesylate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204644
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-28

Drug Details

Active Ingredients

IngredientStrength
IMATINIB MESYLATE100 mg/1

OpenFDA Data

SPL SET ID:a1787fad-3612-43e1-98fa-ce62361e0b3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403878
  • 403879
  • Pharmacological Class

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

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

    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

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