Natesto
These highlights do not include all the information needed to use NATESTO safely and effectively. See full prescribing information for NATESTO. Natesto (testosterone) nasal gel CIII Initial U.S. Approval: 1953
Approved
Approval ID
dea6bed1-eaca-11e3-ac10-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2022
Manufacturers
FDA
Acerus Pharmaceuticals Corporation
DUNS: 243912362
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 Code42667-5511
Application NumberNDA205488
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 19, 2022
FDA Product Classification
INGREDIENTS (4)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
APRICOT KERNEL OILInactive
Code: 54JB35T06A
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
TESTOSTERONEActive
Quantity: 5.5 mg in 0.122 g
Code: 3XMK78S47O
Classification: ACTIB