estradiol
ESTRADIOL transdermal system
Approved
Approval ID
8b672c79-0896-4d6e-b225-299e89068ad7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1401
Application NumberANDA202985
Product Classification
M
Marketing Category
C73584
G
Generic Name
estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 21, 2023
FDA Product Classification
INGREDIENTS (10)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ESTRADIOLActive
Quantity: 0.025 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
2-ETHYLHEXYL ACRYLATEInactive
Code: HR49R9S6XG
Classification: IACT
2-HYDROXYETHYL ACRYLATEInactive
Code: 25GT92NY0C
Classification: IACT
ETHYL OLEATEInactive
Code: Z2Z439864Y
Classification: IACT
GLYCERYL LAURATEInactive
Code: Y98611C087
Classification: IACT
GLYCIDYL METHACRYLATEInactive
Code: R8WN29J8VF
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1403
Application NumberANDA202985
Product Classification
M
Marketing Category
C73584
G
Generic Name
estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 21, 2023
FDA Product Classification
INGREDIENTS (10)
ESTRADIOLActive
Quantity: 0.05 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
2-ETHYLHEXYL ACRYLATEInactive
Code: HR49R9S6XG
Classification: IACT
2-HYDROXYETHYL ACRYLATEInactive
Code: 25GT92NY0C
Classification: IACT
ETHYL OLEATEInactive
Code: Z2Z439864Y
Classification: IACT
GLYCERYL LAURATEInactive
Code: Y98611C087
Classification: IACT
GLYCIDYL METHACRYLATEInactive
Code: R8WN29J8VF
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1404
Application NumberANDA202985
Product Classification
M
Marketing Category
C73584
G
Generic Name
estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 21, 2023
FDA Product Classification
INGREDIENTS (10)
2-HYDROXYETHYL ACRYLATEInactive
Code: 25GT92NY0C
Classification: IACT
ESTRADIOLActive
Quantity: 0.06 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
ETHYL OLEATEInactive
Code: Z2Z439864Y
Classification: IACT
2-ETHYLHEXYL ACRYLATEInactive
Code: HR49R9S6XG
Classification: IACT
GLYCERYL LAURATEInactive
Code: Y98611C087
Classification: IACT
GLYCIDYL METHACRYLATEInactive
Code: R8WN29J8VF
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1402
Application NumberANDA202985
Product Classification
M
Marketing Category
C73584
G
Generic Name
estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 21, 2023
FDA Product Classification
INGREDIENTS (10)
ESTRADIOLActive
Quantity: 0.0375 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
2-ETHYLHEXYL ACRYLATEInactive
Code: HR49R9S6XG
Classification: IACT
2-HYDROXYETHYL ACRYLATEInactive
Code: 25GT92NY0C
Classification: IACT
ETHYL OLEATEInactive
Code: Z2Z439864Y
Classification: IACT
GLYCIDYL METHACRYLATEInactive
Code: R8WN29J8VF
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
GLYCERYL LAURATEInactive
Code: Y98611C087
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1406
Application NumberANDA202985
Product Classification
M
Marketing Category
C73584
G
Generic Name
estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 21, 2023
FDA Product Classification
INGREDIENTS (10)
GLYCERYL LAURATEInactive
Code: Y98611C087
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
ESTRADIOLActive
Quantity: 0.1 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
2-ETHYLHEXYL ACRYLATEInactive
Code: HR49R9S6XG
Classification: IACT
2-HYDROXYETHYL ACRYLATEInactive
Code: 25GT92NY0C
Classification: IACT
ETHYL OLEATEInactive
Code: Z2Z439864Y
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
GLYCIDYL METHACRYLATEInactive
Code: R8WN29J8VF
Classification: IACT
estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1405
Application NumberANDA202985
Product Classification
M
Marketing Category
C73584
G
Generic Name
estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 21, 2023
FDA Product Classification
INGREDIENTS (10)
ESTRADIOLActive
Quantity: 0.075 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
2-ETHYLHEXYL ACRYLATEInactive
Code: HR49R9S6XG
Classification: IACT
ETHYL OLEATEInactive
Code: Z2Z439864Y
Classification: IACT
GLYCERYL LAURATEInactive
Code: Y98611C087
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
GLYCIDYL METHACRYLATEInactive
Code: R8WN29J8VF
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
2-HYDROXYETHYL ACRYLATEInactive
Code: 25GT92NY0C
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT