Label: ESTRADIOL patch, extended release

  • NDC Code(s): 70771-1563-1, 70771-1563-8, 70771-1564-1, 70771-1564-8, view more
    70771-1565-1, 70771-1565-8, 70771-1566-1, 70771-1566-8, 70771-1567-1, 70771-1567-8
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 7, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Package Label – 0.025 mg

    NDC 70771-1563-8

    Estradiol Transdermal System, USP

    (Twice-Weekly)

    Delivers 0.025 mg/day

    Includes 8 Systems

    Rx Only

    zydus pharmaceuticals

    0.025mg
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Package Label – 0.0375 mg

    NDC 70771-1564-8

    Estradiol Transdermal System, USP

    (Twice-Weekly)

    Delivers 0.0375 mg/day

    Includes 8 Systems

    Rx Only

    zydus pharmaceuticals

    0.0375mg
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Package Label – 0.05 mg

    NDC 70771-1565-8

    Estradiol Transdermal System, USP

    (Twice-Weekly)

    Delivers 0.05 mg/day

    Includes 8 Systems

    Rx Only

    zydus pharmaceuticals

    0.05mg
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Package Label – 0.075 mg

    NDC 70771-1566-8

    Estradiol Transdermal System, USP

    (Twice-Weekly)

    Delivers 0.075 mg/day

    Includes 8 Systems

    Rx Only

    zydus pharmaceuticals

    0.075mg
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Package Label – 0.1 mg

    NDC 70771-1567-8

    Estradiol Transdermal System, USP

    (Twice-Weekly)

    Delivers 0.1 mg/day

    Includes 8 Systems

    Rx Only

    zydus pharmaceuticals

    0.1mg
  • INGREDIENTS AND APPEARANCE
    ESTRADIOL 
    estradiol patch, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1563
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.025 mg  in 1 d
    Inactive Ingredients
    Ingredient NameStrength
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1563-88 in 1 BOX04/13/2023
    1NDC:70771-1563-11 in 1 POUCH
    13.5 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20624104/13/2023
    ESTRADIOL 
    estradiol patch, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1564
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.0375 mg  in 1 d
    Inactive Ingredients
    Ingredient NameStrength
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1564-88 in 1 BOX04/13/2023
    1NDC:70771-1564-11 in 1 POUCH
    13.5 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20624104/13/2023
    ESTRADIOL 
    estradiol patch, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1565
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.05 mg  in 1 d
    Inactive Ingredients
    Ingredient NameStrength
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1565-88 in 1 BOX04/13/2023
    1NDC:70771-1565-11 in 1 POUCH
    13.5 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20624104/13/2023
    ESTRADIOL 
    estradiol patch, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1566
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.075 mg  in 1 d
    Inactive Ingredients
    Ingredient NameStrength
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1566-88 in 1 BOX04/13/2023
    1NDC:70771-1566-11 in 1 POUCH
    13.5 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20624104/13/2023
    ESTRADIOL 
    estradiol patch, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1567
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.1 mg  in 1 d
    Inactive Ingredients
    Ingredient NameStrength
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1567-88 in 1 BOX04/13/2023
    1NDC:70771-1567-11 in 1 POUCH
    13.5 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20624104/13/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1563, 70771-1564, 70771-1565, 70771-1566, 70771-1567) , MANUFACTURE(70771-1563, 70771-1564, 70771-1565, 70771-1566, 70771-1567)
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