FDA.reportPublic FDA data

olipudase alfa-rpcp 20 MG Injection [Xenpozyme]

RxCUI
2610416
RxNorm name
olipudase alfa-rpcp 20 MG Injection [Xenpozyme]
Display name
olipudase alfa-rpcp 20 MG Injection [Xenpozyme]
Full name
olipudase alfa-rpcp 20 MG Injection [Xenpozyme]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761261Xenpozymeolipudase alfa-rpcp351(a)Rx2026-07-01

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
XENPOZYMEOLIPUDASE ALFA-RPCPGenzyme Corporation01a910ee-a33e-4be3-ac41-322d64c343112025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2610416

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
01a910ee-a33e-4be3-ac41-322d64c34311Xenpozyme 20 MG Injection [PSN] · olipudase alfa-rpcp 20 MG Injection [Xenpozyme] [SBD] · Xenpozyme 20 MG Injection [SY]310These highlights do not include all the information needed to use XENPOZYME safely and effectively. See full prescribing information for XENPOZYME. XENPOZYME ® (olipudase alfa-rpcp) for injection, for intravenous use Initial U.S. Approval: 202220251211