FDA.reportPublic FDA data

2 ML rozanolixizumab-noli 140 MG/ML Injection

RxCUI
2642288
RxNorm name
2 ML rozanolixizumab-noli 140 MG/ML Injection
Display name
2 ML rozanolixizumab-noli 140 MG/ML Injection
Full name
2 ML rozanolixizumab-noli 140 MG/ML Injection
Term type
SCD
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)Rx2026-06-01

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#

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: 2642288

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3c0eb8c2-c042-4954-b451-3baa77f5e6d12 ML rozanolixizumab-noli 140 MG/ML InjectionSCD10These 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
3c0eb8c2-c042-4954-b451-3baa77f5e6d1rozanolixizumab-noli 280 MG in 2 ML InjectionPSN10These 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
3c0eb8c2-c042-4954-b451-3baa77f5e6d1rozanolixizumab-noli 280 MG per 2 ML InjectionSY10These 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