Label: ESTRADIOL patch

  • NDC Code(s): 70771-1401-1, 70771-1401-4, 70771-1402-1, 70771-1402-4, view more
    70771-1403-1, 70771-1403-4, 70771-1404-1, 70771-1404-4, 70771-1405-1, 70771-1405-4, 70771-1406-1, 70771-1406-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 21, 2023

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  • SPL UNCLASSIFIED

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1401-4

    Estradiol Transdermal System, USP

    0.025 mg/day

    Continuous Delivery (Once-Weekly)

    FOR TRANSDERMAL USE ONLY

    Contains 4 transdermal systems

    Rx only

    zydus Pharmaceuticals USA

    Estradiol Transdermal System USP, 0.025mg per day

    NDC 70771-1402-4

    Estradiol Transdermal System, USP

    0.0375 mg/day

    Continuous Delivery (Once-Weekly)

    FOR TRANSDERMAL USE ONLY

    Contains 4 transdermal systems

    Rx only

    zydus Pharmaceuticals USA

    Estradiol Transdermal System USP, 0.0375mg per day

    NDC 70771-1403-4

    Estradiol Transdermal System, USP

    0.05 mg/day

    Continuous Delivery (Once-Weekly)

    FOR TRANSDERMAL USE ONLY

    Contains 4 transdermal systems

    Rx only

    zydus Pharmaceuticals USA

    Estradiol Transdermal System USP, 0.05mg per day

    NDC 70771-1404-4

    Estradiol Transdermal System, USP

    0.06 mg/day

    Continuous Delivery (Once-Weekly)

    FOR TRANSDERMAL USE ONLY

    Contains 4 transdermal systems

    Rx only

    zydus Pharmaceuticals USA

    Estradiol Transdermal System USP, 0.06mg per day

    NDC 70771-1405-4

    Estradiol Transdermal System, USP

    0.075 mg/day

    Continuous Delivery (Once-Weekly)

    FOR TRANSDERMAL USE ONLY

    Contains 4 transdermal systems

    Rx only

    zydus Pharmaceuticals USA

    Estradiol Transdermal System USP, 0.075mg per day

    NDC 70771-1406-4

    Estradiol Transdermal System, USP

    0.1 mg/day

    Continuous Delivery (Once-Weekly)

    FOR TRANSDERMAL USE ONLY

    Contains 4 transdermal systems

    Rx only

    zydus Pharmaceuticals USA

    Estradiol Transdermal System USP, 0.1mg per day
  • INGREDIENTS AND APPEARANCE
    ESTRADIOL 
    estradiol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1401
    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
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCIDYL METHACRYLATE (UNII: R8WN29J8VF)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1401-44 in 1 CARTON11/02/2023
    1NDC:70771-1401-11 in 1 POUCH
    17 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20298511/02/2023
    ESTRADIOL 
    estradiol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1402
    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
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCIDYL METHACRYLATE (UNII: R8WN29J8VF)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1402-44 in 1 CARTON11/02/2023
    1NDC:70771-1402-11 in 1 POUCH
    17 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20298511/02/2023
    ESTRADIOL 
    estradiol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1403
    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
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCIDYL METHACRYLATE (UNII: R8WN29J8VF)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1403-44 in 1 CARTON11/02/2023
    1NDC:70771-1403-11 in 1 POUCH
    17 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20298511/02/2023
    ESTRADIOL 
    estradiol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1404
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.06 mg  in 1 d
    Inactive Ingredients
    Ingredient NameStrength
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCIDYL METHACRYLATE (UNII: R8WN29J8VF)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1404-44 in 1 CARTON11/02/2023
    1NDC:70771-1404-11 in 1 POUCH
    17 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20298511/02/2023
    ESTRADIOL 
    estradiol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1405
    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
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCIDYL METHACRYLATE (UNII: R8WN29J8VF)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1405-44 in 1 CARTON11/02/2023
    1NDC:70771-1405-11 in 1 POUCH
    17 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20298511/02/2023
    ESTRADIOL 
    estradiol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1406
    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
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCIDYL METHACRYLATE (UNII: R8WN29J8VF)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1406-44 in 1 CARTON11/02/2023
    1NDC:70771-1406-11 in 1 POUCH
    17 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20298511/02/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1401, 70771-1402, 70771-1403, 70771-1404, 70771-1405, 70771-1406) , MANUFACTURE(70771-1401, 70771-1402, 70771-1403, 70771-1404, 70771-1405, 70771-1406)
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