FDA.reportPublic FDA data

ENCELTO 200,000 to 440,000 CELLS Intravitreal Implant

RxCUI
2708843
RxNorm name
ENCELTO 200,000 to 440,000 CELLS Intravitreal Implant
Display name
ENCELTO 200,000 to 440,000 CELLS Intravitreal Implant
Full name
ENCELTO 200,000 to 440,000 CELLS Intravitreal Implant
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125798enceltorevakinagene taroretcel-lwey351(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
ENCELTOREVAKINAGENE TARORETCEL-LWEYNeurotech Pharmaceuticals, Inc.1ae9482a-b478-4e21-9166-b5fd52d3ef9c2026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 2708843

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
1ae9482a-b478-4e21-9166-b5fd52d3ef9cENCELTO 200,000 to 440,000 CELLS Intravitreal Implant [PSN] · revakinagene taroretcel-lwey 440000 CELLS Drug Implant [Encelto] [SBD] · Encelto 200,000 to 440,000 CELLS Intravitreal Implant [SY]32These highlights do not include all the information needed to use ENCELTO™ safely and effectively. See full prescribing information for ENCELTO. ENCELTO (revakinagene taroretcel-lwey) implant, for intravitreal use Initial U.S. Approval: 202520250321