FDA.reportPublic FDA data

pegunigalsidase alfa-iwxj 20 MG in 10 ML Injection

RxCUI
2637456
RxNorm name
pegunigalsidase alfa-iwxj 20 MG in 10 ML Injection
Display name
pegunigalsidase alfa-iwxj 20 MG in 10 ML Injection
Full name
pegunigalsidase alfa-iwxj 20 MG in 10 ML Injection
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
761161Elfabriopegunigalsidase alfa-iwxj351(a)Rx2026-08-01

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
ELFABRIOPEGUNIGALSIDASE ALFAChiesi USA, Inc.6fb674bf-744e-431f-92ef-b2a5a66c8cf32024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2637456

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
6fb674bf-744e-431f-92ef-b2a5a66c8cf3pegunigalsidase alfa-iwxj 20 MG in 10 ML Injection [PSN] · 10 ML pegunigalsidase alfa-iwxj 2 MG/ML Injection [SCD] · pegunigalsidase alfa-iwxj 20 MG per 10 ML Injection [SY]37These highlights do not include all the information needed to use ELFABRIO ® safely and effectively. See full prescribing information for ELFABRIO . ELFABRI O ( pegunigalsidase alfa - iwxj ) injection, for intravenous use Initial U.S. Approval: 202320240708