FDA.reportPublic FDA data

olipudase alfa-rpcp 4 MG Injection

RxCUI
2634357
RxNorm name
olipudase alfa-rpcp 4 MG Injection
Display name
olipudase alfa-rpcp 4 MG Injection
Full name
olipudase alfa-rpcp 4 MG Injection
Term type
PSN
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: 2634357

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-ac41-322d64c34311olipudase alfa-rpcp 4 MG Injection [PSN] · olipudase alfa-rpcp 4 MG Injection [SCD]210These 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