FDA.reportPublic FDA data

remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KG

RxCUI
2706557
RxNorm name
remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KG
Display name
remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KG
Full name
remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KG
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)Rx2026-06-01

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
RYONCILREMESTEMCEL-L-RKNDMesoblasta4e0918f-7444-4694-adeb-d38d983456592025-09-11Warnings, Adverse reactionsExact identifier
rxcui: 2706557

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a4e0918f-7444-4694-adeb-d38d98345659remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KGSY5These 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
a4e0918f-7444-4694-adeb-d38d98345659remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KGPSN5These 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
a4e0918f-7444-4694-adeb-d38d98345659{5 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCK5These 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