FDA.reportPublic FDA data

ibalizumab-uiyk 200 MG per 1.33 ML Injection

RxCUI
2043317
RxNorm name
ibalizumab-uiyk 200 MG per 1.33 ML Injection
Display name
ibalizumab-uiyk 200 MG per 1.33 ML Injection
Full name
ibalizumab-uiyk 200 MG per 1.33 ML Injection
Term type
SY
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
761065Trogarzoibalizumab-uiyk351(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
TROGARZOIBALIZUMABTheratechnologies Inc.c548ad82-9d1f-4d16-95b6-4e6106badf432026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 2043317

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
c548ad82-9d1f-4d16-95b6-4e6106badf43ibalizumab-uiyk 200 MG in 1.33 mL Injection [PSN] · 1.33 ML ibalizumab-uiyk 150 MG/ML Injection [SCD] · ibalizumab-uiyk 200 MG per 1.33 ML Injection [SY]313These highlights do not include all the information needed to use TROGARZO safely and effectively. See full prescribing information for TROGARZO. TROGARZO ® (ibalizumab-uiyk) injection, for intravenous use Initial U.S. Approval: 201820260107