ESTRADIOL- estradiol patch 
Zydus Lifesciences Limited

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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
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)

Revised: 4/2023
Document Id: 7287c5b3-80de-4eab-9905-f597a4fbaf34
Set id: 2f2030c2-f72e-4142-9cff-540bc8fbf8a1
Version: 1
Effective Time: 20230421
 
Zydus Lifesciences Limited