Simponi
These highlights do not include all the information needed to use SIMPONI safely and effectively. See full prescribing information for SIMPONI. SIMPONI (golimumab) injection, for subcutaneous use Initial U.S. Approval: 2009
Approved
Approval ID
f86cb4a7-c358-4136-ae57-b32bda9bba00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Janssen Biotech, Inc.
DUNS: 099091753
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
golimumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57894-071
Application NumberBLA125289
Product Classification
M
Marketing Category
C73585
G
Generic Name
golimumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (6)
HISTIDINEInactive
Quantity: 0.87 mg in 1 mL
Code: 4QD397987E
Classification: IACT
SORBITOLInactive
Quantity: 41 mg in 1 mL
Code: 506T60A25R
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.15 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GOLIMUMABActive
Quantity: 100 mg in 1 mL
Code: 91X1KLU43E
Classification: ACTIB
golimumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57894-070
Application NumberBLA125289
Product Classification
M
Marketing Category
C73585
G
Generic Name
golimumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (6)
POLYSORBATE 80Inactive
Quantity: 0.08 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
GOLIMUMABActive
Quantity: 50 mg in 0.5 mL
Code: 91X1KLU43E
Classification: ACTIB
HISTIDINEInactive
Quantity: 0.44 mg in 0.5 mL
Code: 4QD397987E
Classification: IACT
SORBITOLInactive
Quantity: 20.5 mg in 0.5 mL
Code: 506T60A25R
Classification: IACT