Label: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

  • NDC Code(s): 65841-732-06, 65841-732-10, 65841-732-16, 65841-732-40, view more
    65841-733-06, 65841-733-10, 65841-733-16, 65841-733-23
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-732-06

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg

    30 Tablets

    Rx Only

    losahctz3

    NDC 65841-733-06

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg

    30 Tablets

    Rx Only

    losahctz4
  • INGREDIENTS AND APPEARANCE
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 
    losartan potassium and hydrochlorothiazide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-732
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size12mm
    FlavorImprint Code ZD18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-732-405000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    2NDC:65841-732-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    3NDC:65841-732-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    4NDC:65841-732-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07838504/10/2010
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 
    losartan potassium and hydrochlorothiazide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-733
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size13mm
    FlavorImprint Code ZD19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-733-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    2NDC:65841-733-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    3NDC:65841-733-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    4NDC:65841-733-234000 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07838504/10/2010
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-732, 65841-733) , MANUFACTURE(65841-732, 65841-733)