Label: VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

  • NDC Code(s): 70771-1485-0, 70771-1485-4, 70771-1485-9, 70771-1486-0, view more
    70771-1486-4, 70771-1486-9, 70771-1487-0, 70771-1487-4, 70771-1487-9, 70771-1488-0, 70771-1488-4, 70771-1488-9, 70771-1489-0, 70771-1489-4, 70771-1489-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg

    NDC 70771-1485-0 in bottle of 1000 tablets

    1000 tablets

    Rx only

    80 mg/ 12.5 mg

    Valsartan and Hydrochlorothiazide Tablets USP, 160/12.5 mg

    NDC 70771-1486-0 in bottle of 1000 tablets

    1000 tablets

    Rx only

    160 mg/ 12.5 mg

    Valsartan and Hydrochlorothiazide Tablets USP, 160/25 mg

    NDC 70771-1487-0 in bottle of 1000 tablets

    1000 tablets

    Rx only

    160 mg/ 25 mg

    Valsartan and Hydrochlorothiazide Tablets USP, 320/12.5 mg

    NDC 70771-1488-0 in bottle of 1000 tablets

    1000 tablets

    Rx only

    320 mg/ 12.5 mg

    Valsartan and Hydrochlorothiazide Tablets USP, 320/25 mg

    NDC 70771-1489-0 in bottle of 1000 tablets

    1000 tablets

    Rx only

    320 mg/ 25 mg
  • INGREDIENTS AND APPEARANCE
    VALSARTAN AND HYDROCHLOROTHIAZIDE 
    valsartan and hydrochlorothiazide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1485
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN80 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeOVAL (OVAL) Size12mm
    FlavorImprint Code 279
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1485-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    2NDC:70771-1485-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    3NDC:70771-1485-410 in 1 CARTON02/12/2020
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20300002/12/2020
    VALSARTAN AND HYDROCHLOROTHIAZIDE 
    valsartan and hydrochlorothiazide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1486
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN160 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    Product Characteristics
    ColorBROWN (brownish red) Scoreno score
    ShapeOVAL (OVAL) Size17mm
    FlavorImprint Code 280
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1486-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    2NDC:70771-1486-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    3NDC:70771-1486-410 in 1 CARTON02/12/2020
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20300002/12/2020
    VALSARTAN AND HYDROCHLOROTHIAZIDE 
    valsartan and hydrochlorothiazide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1487
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN160 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    Product Characteristics
    ColorBROWN (BROWN) Scoreno score
    ShapeOVAL (oval) Size17mm
    FlavorImprint Code 282
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1487-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    2NDC:70771-1487-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    3NDC:70771-1487-410 in 1 CARTON02/12/2020
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20300002/12/2020
    VALSARTAN AND HYDROCHLOROTHIAZIDE 
    valsartan and hydrochlorothiazide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN320 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (pink) Scoreno score
    ShapeOVAL (oval) Size21mm
    FlavorImprint Code 281
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1488-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    2NDC:70771-1488-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    3NDC:70771-1488-410 in 1 CARTON02/12/2020
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20300002/12/2020
    VALSARTAN AND HYDROCHLOROTHIAZIDE 
    valsartan and hydrochlorothiazide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1489
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN320 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (BROWN) Scoreno score
    ShapeOVAL (OVAL) Size21mm
    FlavorImprint Code 283
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1489-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    2NDC:70771-1489-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    3NDC:70771-1489-410 in 1 CARTON02/12/2020
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20300002/12/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489) , MANUFACTURE(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489)