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
2dc2ed4b-f234-4ccc-bd95-0b63ac3ef421
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-4490
Application NumberBLA103795
Product Classification
M
Marketing Category
C73585
G
Generic Name
etanercept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 20, 2019
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
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.12 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT