Androgel
These highlights do not include all the information needed to use ANDROGEL 1.62% safely and effectively. See full prescribing information for ANDROGEL 1.62%. AndroGel (testosterone gel) 1.62% for topical use CIII Initial U.S. Approval: 1953
Approved
Approval ID
8677ba5b-8374-46cb-854c-403972e9ddf3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2020
Manufacturers
FDA
AbbVie Inc.
DUNS: 078458370
Products 1
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 Code0051-8462
Application NumberNDA022309
Product Classification
M
Marketing Category
C73594
G
Generic Name
Testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 27, 2023
FDA Product Classification
INGREDIENTS (6)
testosteroneActive
Quantity: 16.2 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT