FDA.reportPublic FDA data

10 ML Elfabrio 2 MG/ML Injection

RxCUI
2637462
RxNorm name
10 ML Elfabrio 2 MG/ML Injection
Display name
10 ML Elfabrio 2 MG/ML Injection
Full name
10 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: 2637462

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 20 MG in 10 ML Injection [PSN] · 10 ML pegunigalsidase alfa-iwxj 2 MG/ML Injection [Elfabrio] [SBD] · 10 ML Elfabrio 2 MG/ML Injection [SY] · Elfabrio 20 MG per 10 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