Label: DOXAZOSIN tablet

  • NDC Code(s): 70771-1112-0, 70771-1112-1, 70771-1112-2, 70771-1112-3, view more
    70771-1112-4, 70771-1113-0, 70771-1113-1, 70771-1113-2, 70771-1113-3, 70771-1113-4, 70771-1114-0, 70771-1114-1, 70771-1114-2, 70771-1114-3, 70771-1114-4, 70771-1115-0, 70771-1115-1, 70771-1115-2, 70771-1115-3, 70771-1115-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 25, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1112-1 in bottle of 100 Tablets

    Doxazosin Tablets USP, 1 mg

    Rx only

    100 Tablets

    container label 1 mg - 100s count

    NDC 70771-1113-1 in bottle of 100 Tablets

    Doxazosin Tablets USP, 2 mg

    Rx only

    100 Tablets

    container label 2 mg- 100s count

    NDC 70771-1114-1 in bottle of 100 Tablets

    Doxazosin Tablets USP, 4 mg

    Rx only

    100 Tablets

    container label 4 mg - 100s count

    NDC 70771-1115-1 in bottle of 100 Tablets

    Doxazosin Tablets USP, 8 mg

    Rx only

    100 Tablets

    container label - 8 mg - 100s count
  • INGREDIENTS AND APPEARANCE
    DOXAZOSIN 
    doxazosin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8) DOXAZOSIN1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND BICONVEX) Size7mm
    FlavorImprint Code 783
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1112-330 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    2NDC:70771-1112-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    3NDC:70771-1112-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    4NDC:70771-1112-410 in 1 CARTON08/31/2017
    4NDC:70771-1112-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20871908/31/2017
    DOXAZOSIN 
    doxazosin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8) DOXAZOSIN2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorPINK (LIGHT PINK TO PINK) Score2 pieces
    ShapeROUND (ROUND BICONVEX) Size7mm
    FlavorImprint Code 784
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1113-330 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    2NDC:70771-1113-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    3NDC:70771-1113-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    4NDC:70771-1113-410 in 1 CARTON08/31/2017
    4NDC:70771-1113-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20871908/31/2017
    DOXAZOSIN 
    doxazosin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8) DOXAZOSIN4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorPINK (LIGHT PINK TO PINK) Score2 pieces
    ShapeCAPSULE (CAPSULE, BICONVEX) Size12mm
    FlavorImprint Code 785
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1114-330 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    2NDC:70771-1114-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    3NDC:70771-1114-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    4NDC:70771-1114-410 in 1 CARTON08/31/2017
    4NDC:70771-1114-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20871908/31/2017
    DOXAZOSIN 
    doxazosin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8) DOXAZOSIN8 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorPURPLE (LIGHT PURPLE TO PURPLE) Score2 pieces
    ShapeROUND (ROUND BICONVEX) Size9mm
    FlavorImprint Code 786
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1115-330 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    2NDC:70771-1115-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    3NDC:70771-1115-410 in 1 CARTON08/31/2017
    3NDC:70771-1115-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70771-1115-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20871908/31/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1112, 70771-1113, 70771-1114, 70771-1115) , MANUFACTURE(70771-1112, 70771-1113, 70771-1114, 70771-1115)
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