ESTRADIOL patch, extended release

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 SECTION

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

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

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

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

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

INGREDIENTS AND APPEARANCE

ESTRADIOL 
estradiol patch, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1563
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
OLEIC ACID (UNII: 2UMI9U37CP)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1563-8	8 in 1 BOX	04/13/2023
1	NDC: 70771-1563-1	1 in 1 POUCH
1		3.5 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	ANDA206241	04/13/2023

ESTRADIOL 
estradiol patch, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1564
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
OLEIC ACID (UNII: 2UMI9U37CP)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1564-8	8 in 1 BOX	04/13/2023
1	NDC: 70771-1564-1	1 in 1 POUCH
1		3.5 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	ANDA206241	04/13/2023

ESTRADIOL 
estradiol patch, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1565
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
OLEIC ACID (UNII: 2UMI9U37CP)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1565-8	8 in 1 BOX	04/13/2023
1	NDC: 70771-1565-1	1 in 1 POUCH
1		3.5 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	ANDA206241	04/13/2023

ESTRADIOL 
estradiol patch, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1566
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
OLEIC ACID (UNII: 2UMI9U37CP)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1566-8	8 in 1 BOX	04/13/2023
1	NDC: 70771-1566-1	1 in 1 POUCH
1		3.5 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	ANDA206241	04/13/2023

ESTRADIOL 
estradiol patch, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1567
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
OLEIC ACID (UNII: 2UMI9U37CP)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1567-8	8 in 1 BOX	04/13/2023
1	NDC: 70771-1567-1	1 in 1 POUCH
1		3.5 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	ANDA206241	04/13/2023

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1563, 70771-1564, 70771-1565, 70771-1566, 70771-1567) , MANUFACTURE(70771-1563, 70771-1564, 70771-1565, 70771-1566, 70771-1567)