XYOSTED
These highlights do not include all the information needed to use XYOSTED safely and effectively. See full prescribing information for XYOSTED. XYOSTED (testosterone enanthate) injection, for subcutaneous useCIIIInitial U.S. approval: 1953
Approved
Approval ID
8a3d204c-be26-49e0-8599-0ac12a272e81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Antares Pharma, Inc.
DUNS: 085369585
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
testosterone enanthate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54436-200
Application NumberNDA209863
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone enanthate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (2)
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
TESTOSTERONE ENANTHATEActive
Quantity: 100 mg in 0.5 mL
Code: 7Z6522T8N9
Classification: ACTIB
testosterone enanthate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54436-275
Application NumberNDA209863
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone enanthate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (2)
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
TESTOSTERONE ENANTHATEActive
Quantity: 75 mg in 0.5 mL
Code: 7Z6522T8N9
Classification: ACTIB
testosterone enanthate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54436-250
Application NumberNDA209863
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone enanthate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (2)
TESTOSTERONE ENANTHATEActive
Quantity: 50 mg in 0.5 mL
Code: 7Z6522T8N9
Classification: ACTIB
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT