NDC Code(s) : 68382-324-01, 68382-324-04, 68382-325-01, 68382-325-04, 68382-326-01, 68382-326-04, 68382-327-01, 68382-327-04, 68382-328-01, 68382-328-04, 68382-329-01, 68382-329-04
Packager : Zydus Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

estradiolestradiol PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-324
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
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
1NDC:68382-324-044 in 1 CARTON 11/02/2023
1NDC:68382-324-011 in 1 POUCH
17 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
estradiolestradiol PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-325
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
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
1NDC:68382-325-044 in 1 CARTON 11/02/2023
1NDC:68382-325-011 in 1 POUCH
17 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
estradiolestradiol PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-326
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
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
1NDC:68382-326-044 in 1 CARTON 11/02/2023
1NDC:68382-326-011 in 1 POUCH
17 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
estradiolestradiol PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-327
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.06 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
1NDC:68382-327-044 in 1 CARTON 11/02/2023
1NDC:68382-327-011 in 1 POUCH
17 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
estradiolestradiol PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-328
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
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
1NDC:68382-328-044 in 1 CARTON 11/02/2023
1NDC:68382-328-011 in 1 POUCH
17 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
estradiolestradiol PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-329
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
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
1NDC:68382-329-044 in 1 CARTON 11/02/2023
1NDC:68382-329-011 in 1 POUCH
17 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 Pharmaceuticals USA Inc.(156861945)

REGISTRANT - ZYDUS NOVELTECH INC, USA(801012530)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 918596198 ANALYSIS(68382-324, 68382-325, 68382-326, 68382-327, 68382-328, 68382-329), MANUFACTURE(68382-324, 68382-325, 68382-326, 68382-327, 68382-328, 68382-329)

PRINCIPAL DISPLAY PANEL

NDC 68382-324-04

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, 0.025 mg/day

NDC 68382-325-04

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, 0.025 mg/dayLabel

NDC 68382-326-04

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, 0.025 mg/day

NDC 68382-327-04

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, 0.025 mg/day

NDC 68382-328-04

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, 0.025 mg/day

NDC 68382-329-04

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, 0.025 mg/day