NDC 0054-0249

Imatinib Mesylate

Imatinib Mesylate

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

Product ID0054-0249_0bc6880d-f1f7-4881-9912-54ba77036982
NDC0054-0249
Product TypeHuman Prescription Drug
Proprietary NameImatinib Mesylate
Generic NameImatinib Mesylate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-09-28
Marketing CategoryANDA / ANDA
Application NumberANDA207586
Labeler NameWest-Ward Pharmaceuticals Corp
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 0054-0249-12

3 BLISTER PACK in 1 CARTON (0054-0249-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2018-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0249-13 [00054024913]

Imatinib Mesylate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-28

NDC 0054-0249-22 [00054024922]

Imatinib Mesylate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-28

NDC 0054-0249-12 [00054024912]

Imatinib Mesylate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-28

Drug Details

Active Ingredients

IngredientStrength
IMATINIB MESYLATE400 mg/1

OpenFDA Data

SPL SET ID:0e9927ab-771e-4c2d-881e-7031c40bf205
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403878
  • 403879
    • UPC Code
  • 0300540249229

    • Pharmacological Class

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