COSENTYX
These highlights do not include all the information needed to use COSENTYX safely and effectively. See full prescribing information for COSENTYX. COSENTYX (secukinumab) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015
Approved
Approval ID
77c4b13e-7df3-42d4-81db-3d0cddb7f67a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
secukinumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0639
Application NumberBLA125504
Product Classification
M
Marketing Category
C73585
G
Generic Name
secukinumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (8)
SECUKINUMABActive
Quantity: 150 mg in 1 mL
Code: DLG4EML025
Classification: ACTIB
HISTIDINEInactive
Quantity: 3.103 mg in 1 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 3.103 mg in 1 mL
Code: X573657P6P
Classification: IACT
METHIONINEInactive
Quantity: 0.746 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.200 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 75.67 mg in 1 mL
Code: 7YIN7J07X4
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
secukinumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-1168
Application NumberBLA761349
Product Classification
M
Marketing Category
C73585
G
Generic Name
secukinumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (8)
HISTIDINEInactive
Quantity: 5.67 mg in 1 mL
Code: 4QD397987E
Classification: IACT
SECUKINUMABActive
Quantity: 25 mg in 1 mL
Code: DLG4EML025
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 13.3 mg in 1 mL
Code: X573657P6P
Classification: IACT
METHIONINEInactive
Quantity: 3.73 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 1.00 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 426 mg in 1 mL
Code: 7YIN7J07X4
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
secukinumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-1070
Application NumberBLA125504
Product Classification
M
Marketing Category
C73585
G
Generic Name
secukinumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (8)
SECUKINUMABActive
Quantity: 300 mg in 2 mL
Code: DLG4EML025
Classification: ACTIB
HISTIDINEInactive
Quantity: 6.206 mg in 2 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 6.206 mg in 2 mL
Code: X573657P6P
Classification: IACT
METHIONINEInactive
Quantity: 1.492 mg in 2 mL
Code: AE28F7PNPL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.40 mg in 2 mL
Code: 6OZP39ZG8H
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 151.34 mg in 2 mL
Code: 7YIN7J07X4
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
secukinumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-1056
Application NumberBLA125504
Product Classification
M
Marketing Category
C73585
G
Generic Name
secukinumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (8)
SECUKINUMABActive
Quantity: 75 mg in 0.5 mL
Code: DLG4EML025
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 1.552 mg in 0.5 mL
Code: X573657P6P
Classification: IACT
HISTIDINEInactive
Quantity: 1.552 mg in 0.5 mL
Code: 4QD397987E
Classification: IACT
METHIONINEInactive
Quantity: 0.373 mg in 0.5 mL
Code: AE28F7PNPL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.10 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 37.83 mg in 0.5 mL
Code: 7YIN7J07X4
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT