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
NDC Product Code50090-4490
Application NumberBLA103795
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJune 20, 2019
Generic Nameetanercept
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