FDA.reportPublic FDA data

riTUXimab-arrx 500 MG in 50 ML Injection

RxCUI
2472335
RxNorm name
riTUXimab-arrx 500 MG in 50 ML Injection
Display name
riTUXimab-arrx 500 MG in 50 ML Injection
Full name
riTUXimab-arrx 500 MG in 50 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761140Riabnirituximab-arrx351(k) BiosimilarRx2026-07-01

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
RiabniRITUXIMAB-ARRXAmgen, Incda1c4de7-0e5b-4f72-97ec-7a8d368f085f2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2472335

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
da1c4de7-0e5b-4f72-97ec-7a8d368f085friTUXimab-arrx 500 MG in 50 ML Injection [PSN] · 50 ML rituximab-arrx 10 MG/ML Injection [SCD] · rituximab-arrx 500 MG per 50 ML Injection [SY]39These highlights do not include all the information needed to use RIABNI safely and effectively. See full prescribing information for RIABNI. RIABNI ® (rituximab-arrx) injection, for intravenous use Initial U.S. Approval: 2020 RIABNI (rituximab-arrx) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the20250912