FDA.reportPublic FDA data

remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML Injection

RxCUI
2700771
RxNorm name
remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML Injection
Display name
remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML Injection
Full name
remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:12

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125706ryoncilremestemcel-L-rknd351(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
RYONCILREMESTEMCEL-L-RKNDMesoblasta4e0918f-7444-4694-adeb-d38d983456592025-09-11Warnings, Adverse reactionsExact identifier
rxcui: 2700771

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
a4e0918f-7444-4694-adeb-d38d98345659remestemcel-L-rknd 25,000,000 CELLS in 3.8 ML Injection [PSN] · 3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [SCD] · remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML Injection [SY]35These highlights do not include all the information needed to use RYONCIL ® safely and effectively. See full prescribing information for RYONCIL ® . RYONCIL ® (remestemcel-L-rknd) suspension for intravenous infusion Initial U.S. Approval: December 202420250911