Label: IRBESARTAN tablet

  • NDC Code(s): 70771-1159-0, 70771-1159-2, 70771-1159-3, 70771-1159-4, view more
    70771-1159-5, 70771-1159-9, 70771-1160-0, 70771-1160-2, 70771-1160-3, 70771-1160-4, 70771-1160-5, 70771-1160-9, 70771-1161-0, 70771-1161-2, 70771-1161-3, 70771-1161-4, 70771-1161-5, 70771-1161-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 13, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1159-0 in bottles of 1000 tablets

     

    Irbesartan Tablets USP, 75 mg

     

    1000 Tablets

     

    Rx Only

    Irbesartan Tablets, USP - 75 mg

    NDC 70771-1160-0 in bottles of 1000 tablets

     

    Irbesartan Tablets USP, 150 mg

     

    1000 Tablets

     

    Rx Only

    Irbsertan Tablets USP, 150 mg

    NDC 70771-1161-0 in bottles of 1000 tablets

     

    Irbesartan Tablets USP, 300 mg

     

    1000 Tablets

     

    Rx Only

    Irbesartan Tablets USP, 300 mg
  • INGREDIENTS AND APPEARANCE
    IRBESARTAN 
    irbesartan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1159
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN75 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size11mm
    FlavorImprint Code ZE53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1159-330 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    2NDC:70771-1159-990 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    3NDC:70771-1159-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    4NDC:70771-1159-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    5NDC:70771-1159-410 in 1 CARTON12/08/2017
    5NDC:70771-1159-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07921312/08/2017
    IRBESARTAN 
    irbesartan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN150 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size13mm
    FlavorImprint Code ZE54
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1160-330 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    2NDC:70771-1160-990 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    3NDC:70771-1160-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    4NDC:70771-1160-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    5NDC:70771-1160-410 in 1 CARTON12/08/2017
    5NDC:70771-1160-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07921312/08/2017
    IRBESARTAN 
    irbesartan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN300 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size17mm
    FlavorImprint Code ZE55
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1161-330 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    2NDC:70771-1161-990 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    3NDC:70771-1161-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    4NDC:70771-1161-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    5NDC:70771-1161-410 in 1 CARTON12/08/2017
    5NDC:70771-1161-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07921312/08/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1159, 70771-1160, 70771-1161) , MANUFACTURE(70771-1159, 70771-1160, 70771-1161)
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