FDA.reportPublic FDA data

Krystexxa 8 MG in 1 ML Injection

RxCUI
1011657
RxNorm name
Krystexxa 8 MG in 1 ML Injection
Display name
Krystexxa 8 MG in 1 ML Injection
Full name
Krystexxa 8 MG in 1 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
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: 1011657

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6e566303-d93a-4130-b764-25749829aa95Krystexxa 8 MG in 1 ML Injection [PSN] · 1 ML pegloticase 8 MG/ML Injection [Krystexxa] [SBD] · Krystexxa (as uricase protein) 8 MG per 1 ML Injection [SY] · Krystexxa 8 MG per 1 ML Injection [SY]41143These 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
5f4574d1-401f-4647-83e5-28c0f4a122a7Krystexxa 8 MG in 1 ML Injection [PSN] · 1 ML pegloticase 8 MG/ML Injection [Krystexxa] [SBD] · Krystexxa (as uricase protein) 8 MG per 1 ML Injection [SY] · Krystexxa 8 MG per 1 ML Injection [SY]45These 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 infusion Initial U.S. Approval: 201020120915