FDA.reportPublic FDA data

sibeprenlimab-szsi 400 MG in 2 ML Prefilled Syringe

RxCUI
2728400
RxNorm name
sibeprenlimab-szsi 400 MG in 2 ML Prefilled Syringe
Display name
sibeprenlimab-szsi 400 MG in 2 ML Prefilled Syringe
Full name
sibeprenlimab-szsi 400 MG in 2 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761434Voyxactsibeprenlimab-szsi351(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
VOYXACTSIBEPRENLIMABOtsuka America Pharmaceutical, Inc.c8a93b32-0676-4704-86dc-cb65f425c6e52026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 2728400

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
c8a93b32-0676-4704-86dc-cb65f425c6e5sibeprenlimab-szsi 400 MG in 2 ML Prefilled Syringe [PSN] · 2 ML sibeprenlimab-szsi 200 MG/ML Prefilled Syringe [SCD] · sibeprenlimab-szsi 400 MG per 2 ML Prefilled Syringe [SY]33These highlights do not include all the information needed to use VOYXACT safely and effectively. See full prescribing information for VOYXACT. VOYXACT ® (sibeprenlimab-szsi) injection, for subcutaneous use Initial U.S. Approval: 202520260317