Label: IMATINIB MESYLATE tablet, film coated

  • NDC Code(s): 70771-1394-5, 70771-1394-9, 70771-1395-2, 70771-1395-3, view more
    70771-1395-5, 70771-1395-8, 70771-1395-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 3, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1394-9

    Imatinib Mesylate Tablets, 100 mg

    90 Tablets

    Rx only

    100 mg

    NDC 70771-1395-9

    Imatinib Mesylate Tablets, 400 mg

    90 Tablets

    Rx only

    400 mg
  • INGREDIENTS AND APPEARANCE
    IMATINIB MESYLATE 
    imatinib mesylate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1394
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI) IMATINIB100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (PALE YELLOW TO YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 244
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1394-990 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
    2NDC:70771-1394-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21065801/21/2021
    IMATINIB MESYLATE 
    imatinib mesylate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1395
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI) IMATINIB400 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (PALE YELLOW TO YELLOW) Score2 pieces
    ShapeOVAL (ovaloid) Size19mm
    FlavorImprint Code 245
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1395-990 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
    2NDC:70771-1395-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
    3NDC:70771-1395-330 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
    4NDC:70771-1395-83 in 1 CARTON01/21/2021
    4NDC:70771-1395-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21065801/21/2021
    Labeler - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1394, 70771-1395) , MANUFACTURE(70771-1394, 70771-1395)