NDC Code(s) : 70710-1191-1, 70710-1191-8, 70710-1192-1, 70710-1192-8, 70710-1193-1, 70710-1193-8, 70710-1194-1, 70710-1194-8, 70710-1195-1, 70710-1195-8
Packager : Zydus Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EstradiolEstradiol PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1191
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.025 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
1NDC:70710-1191-88 in 1 BOX 13/04/2023
1NDC:70710-1191-11 in 1 POUCH
13.5 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
EstradiolEstradiol PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1192
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.0375 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
1NDC:70710-1192-88 in 1 BOX 13/04/2023
1NDC:70710-1192-11 in 1 POUCH
13.5 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
EstradiolEstradiol PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1193
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.05 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
1NDC:70710-1193-88 in 1 BOX 13/04/2023
1NDC:70710-1193-11 in 1 POUCH
13.5 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
EstradiolEstradiol PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1194
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.075 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
1NDC:70710-1194-88 in 1 BOX 13/04/2023
1NDC:70710-1194-11 in 1 POUCH
13.5 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
EstradiolEstradiol PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1195
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.1 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
1NDC:70710-1195-88 in 1 BOX 13/04/2023
1NDC:70710-1195-11 in 1 POUCH
13.5 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 Pharmaceuticals USA Inc.(156861945)

REGISTRANT - ZYDUS NOVELTECH INC, USA(801012530)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 918596198 ANALYSIS(70710-1191, 70710-1192, 70710-1193, 70710-1194, 70710-1195), MANUFACTURE(70710-1191, 70710-1192, 70710-1193, 70710-1194, 70710-1195)

PRINCIPAL DISPLAY PANEL

Package Label – 0.025 mg

NDC 70710-1191-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.025 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.025 mg/day

PRINCIPAL DISPLAY PANEL

Package Label – 0.0375 mg

NDC 70710-1192-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.0375 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.0375 mg/day

PRINCIPAL DISPLAY PANEL

Package Label – 0.05 mg

NDC 70710-1193-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.05 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.05 mg/day

PRINCIPAL DISPLAY PANEL

Package Label – 0.075 mg

NDC 70710-1194-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.075 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.075 mg/day

PRINCIPAL DISPLAY PANEL

Package Label – 0.1 mg

NDC 70710-1195-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.1 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.1 mg/day