FDA.reportPublic FDA data

2.5 ML Elfabrio 2 MG/ML Injection

RxCUI
2676760
RxNorm name
2.5 ML Elfabrio 2 MG/ML Injection
Display name
2.5 ML Elfabrio 2 MG/ML Injection
Full name
2.5 ML Elfabrio 2 MG/ML Injection
Term type
SY
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: 2676760

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-b2a5a66c8cf3ELFABRIO 5 MG in 2.5 ML Injection [PSN] · 2.5 ML pegunigalsidase alfa-iwxj 2 MG/ML Injection [Elfabrio] [SBD] · 2.5 ML Elfabrio 2 MG/ML Injection [SY] · Elfabrio 5 MG per 2.5 ML Injection [SY]47These 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