Label: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE tablet

  • NDC Code(s): 70771-1325-0, 70771-1325-1, 70771-1325-2, 70771-1325-3, view more
    70771-1325-4, 70771-1325-9, 70771-1326-0, 70771-1326-1, 70771-1326-2, 70771-1326-3, 70771-1326-4, 70771-1326-9, 70771-1327-0, 70771-1327-1, 70771-1327-2, 70771-1327-3, 70771-1327-4, 70771-1327-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1325-0 in bottle of 1000 tablets

    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg

    Rx only

    1000 tablets

    Candesartan cilexetil and hydrochlorothiazide  tablets

    NDC 70771-1326-0 in bottle of 1000 tablets

    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg

    Rx only

    1000 tablets

    Candesartan cilexetil and hydrochlorothiazide  tablets

    NDC 70771-1327-0 in bottle of 1000 tablets

    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg

    Rx only

    1000 tablets

    Candesartan cilexetil and hydrochlorothiazide  tablets
  • INGREDIENTS AND APPEARANCE
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
    candesartan cilexetil and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL16 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size10mm
    FlavorImprint Code 19;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1325-330 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    2NDC:70771-1325-990 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    3NDC:70771-1325-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    4NDC:70771-1325-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    5NDC:70771-1325-410 in 1 CARTON04/14/2018
    5NDC:70771-1325-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20346604/14/2018
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
    candesartan cilexetil and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1326
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code 19;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1326-410 in 1 CARTON04/14/2018
    1NDC:70771-1326-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70771-1326-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    3NDC:70771-1326-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    4NDC:70771-1326-990 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    5NDC:70771-1326-330 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20346604/14/2018
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
    candesartan cilexetil and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1327
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code 41;6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1327-330 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    2NDC:70771-1327-990 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    3NDC:70771-1327-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    4NDC:70771-1327-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
    5NDC:70771-1327-410 in 1 CARTON04/14/2018
    5NDC:70771-1327-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20346604/14/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1325, 70771-1326, 70771-1327) , MANUFACTURE(70771-1325, 70771-1326, 70771-1327)