FDA.reportPublic FDA data

50 ML pegloticase 0.16 MG/ML Injection [Krystexxa]

RxCUI
2723381
RxNorm name
50 ML pegloticase 0.16 MG/ML Injection [Krystexxa]
Display name
50 ML pegloticase 0.16 MG/ML Injection [Krystexxa]
Full name
50 ML pegloticase 0.16 MG/ML Injection [Krystexxa]
Term type
SBD
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
125293Krystexxapegloticase351(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
KrystexxaPEGLOTICASEHorizon Therapeutics USA, Inc.6e566303-d93a-4130-b764-25749829aa952026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2723381

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
6e566303-d93a-4130-b764-25749829aa95KRYSTEXXA 8 MG in 50 ML Injection [PSN] · 50 ML pegloticase 0.16 MG/ML Injection [Krystexxa] [SBD] · Krystexxa 8 MG per 50 ML Injection [SY]31143These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 201020260528