FDA.reportPublic FDA data

50 ML Praxbind 50 MG/ML Injection

RxCUI
1716200
RxNorm name
50 ML Praxbind 50 MG/ML Injection
Display name
50 ML Praxbind 50 MG/ML Injection
Full name
50 ML Praxbind 50 MG/ML Injection
Term type
SY
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)Rx2026-09-01

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
PraxbindIDARUCIZUMABBoehringer Ingelheim Pharmaceuticals, Inc.c7400f8a-dcf4-a6df-6d07-983081b1bf342024-01-23Warnings, Adverse reactionsExact identifier
rxcui: 1716200

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c7400f8a-dcf4-a6df-6d07-983081b1bf34Praxbind 2.5 GM in 50 ML Injection [PSN] · 50 ML idarucizumab 50 MG/ML Injection [Praxbind] [SBD] · 50 ML Praxbind 50 MG/ML Injection [SY] · Praxbind 2.5 GM per 50 ML Injection [SY]48These 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