Label: LOSARTAN POTASSIUM tablet, film coated

  • NDC Code(s): 65841-729-01, 65841-729-06, 65841-729-10, 65841-729-16, view more
    65841-729-24, 65841-730-01, 65841-730-06, 65841-730-10, 65841-730-16, 65841-730-24, 65841-731-01, 65841-731-06, 65841-731-10, 65841-731-16, 65841-731-30, 65841-731-77
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated September 1, 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 65841-729-01

    Losartan Potassium Tablets USP, 25 mg

    Rx Only

    100 Tablets

    Zydus

    losapotatabA

    NDC 65841-730-01

    Losartan Potassium Tablets USP, 50 mg

    Rx Only

    100 Tablets

    Zydus

    losapotatabB

    NDC 65841-731-01

    Losartan Potassium Tablets USP, 100 mg

    Rx Only

    100 Tablets

    Zydus

    losapotatabC
  • INGREDIENTS AND APPEARANCE
    LOSARTAN POTASSIUM 
    losartan potassium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-729
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM25 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) Size8mm
    FlavorImprint Code Z;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-729-0630 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    2NDC:65841-729-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    3NDC:65841-729-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    4NDC:65841-729-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    5NDC:65841-729-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07824310/04/2010
    LOSARTAN POTASSIUM 
    losartan potassium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-730
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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) Score2 pieces
    ShapeCAPSULE (CAPSULE) Size11mm
    FlavorImprint Code Z16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-730-0630 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    2NDC:65841-730-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    3NDC:65841-730-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    4NDC:65841-730-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    5NDC:65841-730-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07824310/04/2010
    LOSARTAN POTASSIUM 
    losartan potassium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-731
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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) Size12mm
    FlavorImprint Code Z18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-731-0630 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    2NDC:65841-731-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    3NDC:65841-731-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    4NDC:65841-731-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2010
    5NDC:65841-731-7710 in 1 CARTON10/04/2010
    5NDC:65841-731-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07824310/04/2010
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-729, 65841-730, 65841-731) , MANUFACTURE(65841-729, 65841-730, 65841-731)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-729, 65841-730, 65841-731) , MANUFACTURE(65841-729, 65841-730, 65841-731)