FDA.reportPublic FDA data

zolbetuximab-clzb 300 MG Injection

RxCUI
2710430
RxNorm name
zolbetuximab-clzb 300 MG Injection
Display name
zolbetuximab-clzb 300 MG Injection
Full name
zolbetuximab-clzb 300 MG Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761365Vyloyzolbetuximab-clzb351(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
VYLOYZOLBETUXIMABAstellas Pharma US, Inc.e7695a21-abb6-47ac-93f8-0ece5a9c44092025-06-12Warnings, Adverse reactionsExact identifier
rxcui: 2710430

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
e7695a21-abb6-47ac-93f8-0ece5a9c4409zolbetuximab-clzb 300 MG InjectionSCD4These highlights do not include all the information needed to use VYLOY safely and effectively. See full prescribing information for VYLOY. VYLOY ® (zolbetuximab-clzb) for injection, for intravenous use Initial U.S. Approval: 202420250612
e7695a21-abb6-47ac-93f8-0ece5a9c4409zolbetuximab-clzb 300 MG InjectionPSN4These highlights do not include all the information needed to use VYLOY safely and effectively. See full prescribing information for VYLOY. VYLOY ® (zolbetuximab-clzb) for injection, for intravenous use Initial U.S. Approval: 202420250612