estradiol by Zydus Lifesciences Limited ESTRADIOL patch

estradiol by

Drug Labeling and Warnings

estradiol by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

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

INGREDIENTS AND APPEARANCE

ESTRADIOL 
estradiol patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1401
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	0.025 mg  in 1 d

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1401-4	4 in 1 CARTON	11/02/2023
1	NDC: 70771-1401-1	1 in 1 POUCH
1		7 d in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202985	11/02/2023

ESTRADIOL 
estradiol patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1402
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	0.0375 mg  in 1 d

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1402-4	4 in 1 CARTON	11/02/2023
1	NDC: 70771-1402-1	1 in 1 POUCH
1		7 d in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202985	11/02/2023

ESTRADIOL 
estradiol patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1403
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	0.05 mg  in 1 d

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1403-4	4 in 1 CARTON	11/02/2023
1	NDC: 70771-1403-1	1 in 1 POUCH
1		7 d in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202985	11/02/2023

ESTRADIOL 
estradiol patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1404
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	0.06 mg  in 1 d

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1404-4	4 in 1 CARTON	11/02/2023
1	NDC: 70771-1404-1	1 in 1 POUCH
1		7 d in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202985	11/02/2023

ESTRADIOL 
estradiol patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1405
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	0.075 mg  in 1 d

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1405-4	4 in 1 CARTON	11/02/2023
1	NDC: 70771-1405-1	1 in 1 POUCH
1		7 d in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202985	11/02/2023

ESTRADIOL 
estradiol patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1406
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	0.1 mg  in 1 d

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1406-4	4 in 1 CARTON	11/02/2023
1	NDC: 70771-1406-1	1 in 1 POUCH
1		7 d in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202985	11/02/2023

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(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)