FDA.reportPublic FDA data

etanercept 50 MG per 1 ML Auto-Injector

RxCUI
1653223
RxNorm name
etanercept 50 MG per 1 ML Auto-Injector
Display name
etanercept 50 MG per 1 ML Auto-Injector
Full name
etanercept 50 MG per 1 ML Auto-Injector
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103795Enbreletanercept351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENBRELETANERCEPTImmunex Corporationa002b40c-097d-47a5-957f-7a7b1807af7f2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1653223

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a002b40c-097d-47a5-957f-7a7b1807af7fetanercept 50 MG in 1 mL Auto-InjectorPSN218These 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: 199820260511
a002b40c-097d-47a5-957f-7a7b1807af7f1 ML etanercept 50 MG/ML Auto-InjectorSCD218These 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: 199820260511
a002b40c-097d-47a5-957f-7a7b1807af7fetanercept 50 MG per 1 ML Auto-InjectorSY218These 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: 199820260511
74bead6e-b746-4134-817f-0c053ef9e4511 ML etanercept 50 MG/ML Auto-InjectorSCD11These 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: 199820210616
74bead6e-b746-4134-817f-0c053ef9e451etanercept 50 MG in 1 mL Auto-InjectorPSN11These 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: 199820210616
74bead6e-b746-4134-817f-0c053ef9e451etanercept 50 MG per 1 ML Auto-InjectorSY11These 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: 199820210616