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
74bead6e-b746-4134-817f-0c053ef9e451
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2021
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
NDC Product Code50090-3531
Application NumberBLA103795
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateApril 13, 2021
Generic Nameetanercept
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