ENBREL
These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL (etanercept) injection, for subcutaneous use ENBREL (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998
Approved
Approval ID
a002b40c-097d-47a5-957f-7a7b1807af7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Immunex Corporation
DUNS: 028134799
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-010
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 0.06 mmol in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
ETANERCEPTActive
Quantity: 25 mg in 0.5 mL
Code: OP401G7OJC
Classification: ACTIB
SUCROSEInactive
Quantity: 5 mg in 0.5 mL
Code: C151H8M554
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Quantity: 0.013 mmol in 0.5 mL
Code: F7LTH1E20Y
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-455
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 0.06 mmol in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
ETANERCEPTActive
Quantity: 25 mg in 0.5 mL
Code: OP401G7OJC
Classification: ACTIB
ARGININE HYDROCHLORIDEInactive
Quantity: 0.013 mmol in 0.5 mL
Code: F7LTH1E20Y
Classification: IACT
SUCROSEInactive
Quantity: 5 mg in 0.5 mL
Code: C151H8M554
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-044
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
ETANERCEPTActive
Quantity: 50 mg in 1 mL
Code: OP401G7OJC
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Quantity: 0.025 mmol in 1 mL
Code: F7LTH1E20Y
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-435
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
ARGININE HYDROCHLORIDEInactive
Quantity: 0.025 mmol in 1 mL
Code: F7LTH1E20Y
Classification: IACT
ETANERCEPTActive
Quantity: 50 mg in 1 mL
Code: OP401G7OJC
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-456
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
ETANERCEPTActive
Quantity: 50 mg in 1 mL
Code: OP401G7OJC
Classification: ACTIB
ARGININE HYDROCHLORIDEInactive
Quantity: 0.025 mmol in 1 mL
Code: F7LTH1E20Y
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-032
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
ETANERCEPTActive
Quantity: 50 mg in 1 mL
Code: OP401G7OJC
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Quantity: 0.025 mmol in 1 mL
Code: F7LTH1E20Y
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-446
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
ETANERCEPTActive
Quantity: 50 mg in 1 mL
Code: OP401G7OJC
Classification: ACTIB
ARGININE HYDROCHLORIDEInactive
Quantity: 0.025 mmol in 1 mL
Code: F7LTH1E20Y
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-425
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Effective DateDecember 6, 2023
FDA Product Classification
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-445
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
ETANERCEPTActive
Quantity: 50 mg in 1 mL
Code: OP401G7OJC
Classification: ACTIB
ARGININE HYDROCHLORIDEInactive
Quantity: 0.025 mmol in 1 mL
Code: F7LTH1E20Y
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
etanercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58406-021
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (4)
ETANERCEPTActive
Quantity: 50 mg in 1 mL
Code: OP401G7OJC
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Quantity: 0.025 mmol in 1 mL
Code: F7LTH1E20Y
Classification: IACT