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)Rx2026-06-01

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
VOYXACTSIBEPRENLIMABOtsuka America Pharmaceutical, Inc.c8a93b32-0676-4704-86dc-cb65f425c6e52026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 2728400

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c8a93b32-0676-4704-86dc-cb65f425c6e5sibeprenlimab-szsi 400 MG in 2 ML Prefilled SyringePSN3These 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
c8a93b32-0676-4704-86dc-cb65f425c6e52 ML sibeprenlimab-szsi 200 MG/ML Prefilled SyringeSCD3These 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
c8a93b32-0676-4704-86dc-cb65f425c6e5sibeprenlimab-szsi 400 MG per 2 ML Prefilled SyringeSY3These 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