Label: ESTRADIOL patch

  • NDC Code(s): 70771-1400-1, 70771-1400-4
  • 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 70771-1400-4

    Estradiol Transdermal System, USP

    0.014 mg/day

    Apply one transdermal system per week.

    For Transdermal Use Only

    Contents: 4 Transdermal Systems

    Rx Only

    zydus Pharmaceuticals USA

    Estradiol Transdermal System USP 0.014 mg
  • INGREDIENTS AND APPEARANCE
    ESTRADIOL 
    estradiol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1400
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.014 mg  in 1 d
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    POVIDONE (UNII: FZ989GH94E)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    GLYCIDYL METHACRYLATE (UNII: R8WN29J8VF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1400-44 in 1 CARTON11/02/2023
    1NDC:70771-1400-11 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
    ANDAANDA20437911/02/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1400) , MANUFACTURE(70771-1400)
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