ESTRADIOL- estradiol patch, extended release 
Zydus Lifesciences Limited

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ESTRADIOL transdermal system, USP (TWICE-WEEKLY)

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
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)

Revised: 12/2022
Document Id: 260eb67a-a1fc-4dae-9f69-345ea6ad9f83
Set id: b79fd5ea-962f-491c-b670-40efe42ccf79
Version: 1
Effective Time: 20221207
 
Zydus Lifesciences Limited