Testosterone
These highlights do not include all the information needed to use TESTOSTERONE GEL 1% safely and effectively. See full prescribing information for TESTOSTERONE GEL 1%. TESTOSTERONE Gel 1%, for topical use CIIIInitial U.S. Approval: 1953
Approved
Approval ID
20c26428-81fe-4edb-99ee-637006b10635
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2020
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
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 Code49884-510
Application NumberANDA076744
Product Classification
M
Marketing Category
C73584
G
Generic Name
Testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TESTOSTERONEActive
Quantity: 50 mg in 5 g
Code: 3XMK78S47O
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
Testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-418
Application NumberANDA076744
Product Classification
M
Marketing Category
C73584
G
Generic Name
Testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TESTOSTERONEActive
Quantity: 25 mg in 2.5 g
Code: 3XMK78S47O
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT