Androgel
These highlights do not include all the information needed to use AndroGel safely and effectively. See full prescribing information for AndroGel.AndroGel (testosterone gel) 1% for topical use CIIIInitial U.S. Approval: 1953
Approved
Approval ID
d466910c-9a76-44e8-8759-4717ec2c591f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5814
Application NumberNDA021015
Product Classification
M
Marketing Category
C73594
G
Generic Name
Testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (6)
carbomer homopolymer type CInactive
Code: 4Q93RCW27E
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
testosteroneActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
Testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4810
Application NumberNDA021015
Product Classification
M
Marketing Category
C73594
G
Generic Name
Testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (6)
testosteroneActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
carbomer homopolymer type CInactive
Code: 4Q93RCW27E
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4792
Application NumberNDA021015
Product Classification
M
Marketing Category
C73594
G
Generic Name
Testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (6)
testosteroneActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
carbomer homopolymer type CInactive
Code: 4Q93RCW27E
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT