FDA.reportPublic FDA data

50 ML rituximab-pvvr 10 MG/ML Injection [Ruxience]

RxCUI
2273521
RxNorm name
50 ML rituximab-pvvr 10 MG/ML Injection [Ruxience]
Display name
50 ML rituximab-pvvr 10 MG/ML Injection [Ruxience]
Full name
50 ML rituximab-pvvr 10 MG/ML Injection [Ruxience]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761103Ruxiencerituximab-pvvr351(k) BiosimilarRx2026-08-01

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.

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
f941fc61-f7a3-4e4a-ab7c-87c1667fa05bRuxience 500 MG in 50 ML Injection [PSN] · 50 ML rituximab-pvvr 10 MG/ML Injection [Ruxience] [SBD] · 50 ML Ruxience 10 MG/ML Injection [SY] · Ruxience 500 MG per 50 ML Injection [SY]411These highlights do not include all the information needed to use RUXIENCE safely and effectively. See full prescribing information for RUXIENCE. RUXIENCE ® (rituximab-pvvr) injection, for intravenous use Initial U.S. Approval: 2019 RUXIENCE (rituximab-pvvr) 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 bet20260408