Label: CANDESARTAN CILEXETIL tablet

  • NDC Code(s): 70771-1204-3, 70771-1204-5, 70771-1204-9, 70771-1205-3, view more
    70771-1205-5, 70771-1205-9, 70771-1206-0, 70771-1206-1, 70771-1206-3, 70771-1206-5, 70771-1206-9, 70771-1207-0, 70771-1207-1, 70771-1207-3, 70771-1207-5, 70771-1207-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 14, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1204-5

    Candesartan Cilexetil Tablets USP, 4 mg

    Rx Only

    500 tablets

    labels

    NDC 70771-1205-5

    Candesartan Cilexetil Tablets USP, 8 mg

    Rx Only

    500 tablets

    labels

    NDC 70771-1206-5

    Candesartan Cilexetil Tablets USP, 16 mg

    Rx Only

    500 tablets

    labels

    NDC 70771-1207-5

    Candesartan Cilexetil Tablets USP, 32 mg

    Rx Only

    500 tablets

    labels
  • INGREDIENTS AND APPEARANCE
    CANDESARTAN CILEXETIL 
    candesartan cilexetil tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (LIGHT PINK) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZE;58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1204-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    2NDC:70771-1204-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    3NDC:70771-1204-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09139002/22/2018
    CANDESARTAN CILEXETIL 
    candesartan cilexetil tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1205
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL8 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (PINK) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZE;59
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1205-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    2NDC:70771-1205-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    3NDC:70771-1205-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09139002/22/2018
    CANDESARTAN CILEXETIL 
    candesartan cilexetil tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL16 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZE;60
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1206-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    2NDC:70771-1206-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    3NDC:70771-1206-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    4NDC:70771-1206-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    5NDC:70771-1206-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09139002/22/2018
    CANDESARTAN CILEXETIL 
    candesartan cilexetil tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1207
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code ZE;61
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1207-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    2NDC:70771-1207-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    3NDC:70771-1207-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    4NDC:70771-1207-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    5NDC:70771-1207-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09139002/22/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1204, 70771-1205, 70771-1206, 70771-1207) , MANUFACTURE(70771-1204, 70771-1205, 70771-1206, 70771-1207)