FDA.reportPublic FDA data

taliglucerase alfa 200 UNT Injection

RxCUI
1292879
RxNorm name
taliglucerase alfa 200 UNT Injection
Display name
taliglucerase alfa 200 UNT Injection
Full name
taliglucerase alfa 200 UNT Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022458Elelysotaliglucerase alfa351(a)Rx2026-06-01

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#

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
ELELYSOTALIGLUCERASE ALFAPfizer Laboratories Div Pfizer Incfa3cbd5d-677c-4b19-9032-d9182cb69a832025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1292879

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
fa3cbd5d-677c-4b19-9032-d9182cb69a83taliglucerase alfa 200 UNT InjectionSCD31These highlights do not include all the information needed to use ELELYSO safely and effectively. See full prescribing information for ELELYSO. ELELYSO ® (taliglucerase alfa) for injection, for intravenous use Initial U.S. Approval: 201220251229
fa3cbd5d-677c-4b19-9032-d9182cb69a83taliglucerase alfa 200 UNT InjectionPSN31These highlights do not include all the information needed to use ELELYSO safely and effectively. See full prescribing information for ELELYSO. ELELYSO ® (taliglucerase alfa) for injection, for intravenous use Initial U.S. Approval: 201220251229