ESTRADIOL- estradiol patch 
Zydus Lifesciences Limited

----------

ESTRADIOL transdermal system

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
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)

Revised: 4/2023
Document Id: 93d304a6-249a-4887-9a4a-dfedbd209cc1
Set id: 8b672c79-0896-4d6e-b225-299e89068ad7
Version: 1
Effective Time: 20230421
 
Zydus Lifesciences Limited