Tremfya
These highlights do not include all the information needed to use TREMFYA safely and effectively. See full prescribing information for TREMFYA. TREMFYA (guselkumab) injection for subcutaneous use Initial U.S. Approval: 2017
Approved
Approval ID
1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Janssen Biotech, Inc.
DUNS: 099091753
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Guselkumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57894-640
Application NumberBLA761061
Product Classification
M
Marketing Category
C73585
G
Generic Name
Guselkumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (6)
HISTIDINEInactive
Quantity: 0.6 mg in 1 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 1.5 mg in 1 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Quantity: 79 mg in 1 mL
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GUSELKUMABActive
Quantity: 100 mg in 1 mL
Code: 089658A12D
Classification: ACTIB