Aveed
These highlights do not include all the information needed to use AVEED safely and effectively. See full prescribing information for AVEED. AVEED (testosterone undecanoate) injection, CIIIInitial U.S. Approval: 1953
Approved
Approval ID
f80f025b-17d8-40af-8739-20ce07902045
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2021
Manufacturers
FDA
Endo Pharmaceuticals Inc.
DUNS: 178074951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
testosterone undecanoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67979-511
Application NumberNDA022219
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone undecanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (3)
TESTOSTERONE UNDECANOATEActive
Quantity: 250 mg in 1 mL
Code: H16A5VCT9C
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT