FDA.reportPublic FDA data

ENTYVIO PEN 108 MG in 0.68 ML Auto-Injector

RxCUI
2667342
RxNorm name
ENTYVIO PEN 108 MG in 0.68 ML Auto-Injector
Display name
ENTYVIO PEN 108 MG in 0.68 ML Auto-Injector
Full name
ENTYVIO PEN 108 MG in 0.68 ML Auto-Injector
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761133Entyviovedolizumab351(a)Rx2026-09-01
125476Entyviovedolizumab351(a)Rx2026-09-01

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENTYVIOVEDOLIZUMABTakeda Pharmaceuticals America, Inc.6e94621c-1a95-4af9-98d1-52b9e6f1949c2026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 2667342

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6e94621c-1a95-4af9-98d1-52b9e6f1949cENTYVIO PEN 108 MG in 0.68 ML Auto-Injector [PSN] · 0.68 ML vedolizumab 159 MG/ML Auto-Injector [Entyvio] [SBD] · 0.68 ML Entyvio 159 MG/ML Auto-Injector [SY] · Entyvio 108 MG per 0.68 ML Auto-Injector [SY]426These highlights do not include all the information needed to use ENTYVIO ® safely and effectively. See full prescribing information for ENTYVIO. ENTYVIO (vedolizumab) for injection, for intravenous use ENTYVIO (vedolizumab) injection, for subcutaneous use ENTYVIO PEN (vedolizumab) injection, for subcutaneous use Initial U.S. Approval: 201420260429