FDA.reportPublic FDA data

RYSTIGGO 840 MG in 6 ML Injection

RxCUI
2685619
RxNorm name
RYSTIGGO 840 MG in 6 ML Injection
Display name
RYSTIGGO 840 MG in 6 ML Injection
Full name
RYSTIGGO 840 MG in 6 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761286Rystiggorozanolixizumab-noli351(a)Rx2026-08-01

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.

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
RYSTIGGOROZANOLIXIZUMABUCB, Inc.3c0eb8c2-c042-4954-b451-3baa77f5e6d12026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 2685619

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
3c0eb8c2-c042-4954-b451-3baa77f5e6d1RYSTIGGO 840 MG in 6 ML Injection [PSN] · 6 ML rozanolixizumab-noli 140 MG/ML Injection [Rystiggo] [SBD] · Rystiggo 840 MG per 6 ML Injection [SY]310These highlights do not include all the information needed to use RYSTIGGO safely and effectively. See full prescribing information for RYSTIGGO. RYSTIGGO ® (rozanolixizumab-noli) injection, for subcutaneous use Initial U.S. Approval: 202320260120