Label: PIOGLITAZONE tablet

  • NDC Code(s): 70771-1021-0, 70771-1021-1, 70771-1021-3, 70771-1021-4, view more
    70771-1021-5, 70771-1021-9, 70771-1022-0, 70771-1022-1, 70771-1022-3, 70771-1022-4, 70771-1022-5, 70771-1022-9, 70771-1023-0, 70771-1023-1, 70771-1023-3, 70771-1023-4, 70771-1023-5, 70771-1023-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2023

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  • MEDICATION GUIDE

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1021-3 in bottle of 30 tablets

    Pioglitazone Tablets USP, 15 mg

    Rx only

    30 tablets

    Pioglitazone Tablets USP, 15 mg

    NDC 70771-1022-3 in bottle of 30 tablets

    Pioglitazone Tablets USP, 30 mg

    Rx only

    30 tablets

    Pioglitazone Tablets USP, 30 mg

    NDC 70771-1023-3 in bottle of 30 tablets

    Pioglitazone Tablets USP, 45 mg

    Rx only

    30 tablets

    Pioglitazone Tablets USP, 45 mg
  • INGREDIENTS AND APPEARANCE
    PIOGLITAZONE 
    pioglitazone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S) PIOGLITAZONE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Product Characteristics
    ColorWHITE (off-white to cream white) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code 306
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1021-330 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    2NDC:70771-1021-990 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    3NDC:70771-1021-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    4NDC:70771-1021-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    5NDC:70771-1021-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    6NDC:70771-1021-410 in 1 CARTON11/16/2016
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20245611/16/2016
    PIOGLITAZONE 
    pioglitazone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S) PIOGLITAZONE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Product Characteristics
    ColorWHITE (off-white to cream white) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 307
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1022-330 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    2NDC:70771-1022-990 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    3NDC:70771-1022-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    4NDC:70771-1022-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    5NDC:70771-1022-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    6NDC:70771-1022-410 in 1 CARTON11/16/2016
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20245611/16/2016
    PIOGLITAZONE 
    pioglitazone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S) PIOGLITAZONE45 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Product Characteristics
    ColorWHITE (off-white to cream white) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 308
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1023-330 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    2NDC:70771-1023-990 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    3NDC:70771-1023-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    4NDC:70771-1023-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    5NDC:70771-1023-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    6NDC:70771-1023-410 in 1 CARTON11/16/2016
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20245611/16/2016
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1021, 70771-1022, 70771-1023) , MANUFACTURE(70771-1021, 70771-1022, 70771-1023)
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