Estradiol
These highlights do not include all the information needed to use estradiol gel 0.1% safely and effectively. See full prescribing information for estradiol gel 0.1%. E STRADIOL GEL, for topical use Initial U.S. Approval: 1975
Approved
Approval ID
1a46efe6-21b9-3f0f-90b9-59f279ef51df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Xiromed, LLC
DUNS: 080228637
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Estradiol Gel 0.1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-145
Application NumberANDA211783
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol Gel 0.1%
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Carbomer Homopolymer Type B (Allyl Pentaerythritol Or Allyl Sucrose Crosslinked)Inactive
Code: K6MOM3T5YL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ESTRADIOLActive
Quantity: 1 mg in 1 g
Code: 4TI98Z838E
Classification: ACTIB
Estradiol Gel 0.1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-143
Application NumberANDA211783
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol Gel 0.1%
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
Carbomer Homopolymer Type B (Allyl Pentaerythritol Or Allyl Sucrose Crosslinked)Inactive
Code: K6MOM3T5YL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ESTRADIOLActive
Quantity: 0.25 mg in 0.25 g
Code: 4TI98Z838E
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Estradiol Gel 0.1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-194
Application NumberANDA211783
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol Gel 0.1%
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Carbomer Homopolymer Type B (Allyl Pentaerythritol Or Allyl Sucrose Crosslinked)Inactive
Code: K6MOM3T5YL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ESTRADIOLActive
Quantity: 0.75 mg in 0.75 g
Code: 4TI98Z838E
Classification: ACTIB
Estradiol Gel 0.1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-195
Application NumberANDA211783
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol Gel 0.1%
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
Carbomer Homopolymer Type B (Allyl Pentaerythritol Or Allyl Sucrose Crosslinked)Inactive
Code: K6MOM3T5YL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ESTRADIOLActive
Quantity: 1.25 mg in 1.25 g
Code: 4TI98Z838E
Classification: ACTIB
Estradiol Gel 0.1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-144
Application NumberANDA211783
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol Gel 0.1%
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
Carbomer Homopolymer Type B (Allyl Pentaerythritol Or Allyl Sucrose Crosslinked)Inactive
Code: K6MOM3T5YL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ESTRADIOLActive
Quantity: 0.5 mg in 0.5 g
Code: 4TI98Z838E
Classification: ACTIB