Thyrogen
These highlights do not include all the information needed to use THYROGEN safely and effectively. See full prescribing information for THYROGEN. THYROGEN (thyrotropin alfa) for injection, for intramuscular use Initial U.S. Approval: 1998
Approved
Approval ID
b52dfa36-f90b-4e19-9b5e-26db9d04df2b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2023
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
THYROTROPIN ALFA
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0030
Application NumberBLA020898
Product Classification
M
Marketing Category
C73585
G
Generic Name
THYROTROPIN ALFA
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateFebruary 24, 2023
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Quantity: 30 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
THYROTROPIN ALFAActive
Quantity: 0.9 mg in 1 mL
Code: AVX3D5A4LM
Classification: ACTIB
SODIUM PHOSPHATEInactive
Quantity: 4.25 mg in 1 mL
Code: SE337SVY37
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
THYROTROPIN ALFA
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-1849
Application NumberBLA020898
Product Classification
M
Marketing Category
C73585
G
Generic Name
THYROTROPIN ALFA
Product Specifications
Effective DateFebruary 24, 2023
FDA Product Classification