FDA.reportPublic FDA data

idaruCIZUmab 2.5 GM in 50 ML Injection

RxCUI
1716195
RxNorm name
idaruCIZUmab 2.5 GM in 50 ML Injection
Display name
idaruCIZUmab 2.5 GM in 50 ML Injection
Full name
idaruCIZUmab 2.5 GM in 50 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761025Praxbindidarucizumab351(a)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PraxbindIDARUCIZUMABBoehringer Ingelheim Pharmaceuticals, Inc.c7400f8a-dcf4-a6df-6d07-983081b1bf342024-01-23Warnings, Adverse reactionsExact identifier
rxcui: 1716195

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c7400f8a-dcf4-a6df-6d07-983081b1bf34idaruCIZUmab 2.5 GM in 50 ML InjectionPSN8These highlights do not include all the information needed to use PRAXBIND safely and effectively. See full prescribing information for PRAXBIND. PRAXBIND ® (idarucizumab) injection, for intravenous use Initial U.S. Approval: 201520240123
c7400f8a-dcf4-a6df-6d07-983081b1bf34idarucizumab 2.5 GM per 50 ML InjectionSY8These highlights do not include all the information needed to use PRAXBIND safely and effectively. See full prescribing information for PRAXBIND. PRAXBIND ® (idarucizumab) injection, for intravenous use Initial U.S. Approval: 201520240123
c7400f8a-dcf4-a6df-6d07-983081b1bf3450 ML idarucizumab 50 MG/ML InjectionSCD8These highlights do not include all the information needed to use PRAXBIND safely and effectively. See full prescribing information for PRAXBIND. PRAXBIND ® (idarucizumab) injection, for intravenous use Initial U.S. Approval: 201520240123