FDA.reportPublic FDA data

teprotumumab-trbw 500 MG Injection [Tepezza]

RxCUI
2274812
RxNorm name
teprotumumab-trbw 500 MG Injection [Tepezza]
Display name
teprotumumab-trbw 500 MG Injection [Tepezza]
Full name
teprotumumab-trbw 500 MG Injection [Tepezza]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761143Tepezzateprotumumab-trbw351(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
TEPEZZATEPROTUMUMABHorizon Therapeutics USA, Inc.3e6c54a1-cefd-4a5b-a855-ab9f268b6cce2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2274812

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3e6c54a1-cefd-4a5b-a855-ab9f268b6cceteprotumumab-trbw 500 MG Injection [Tepezza]SBD17These highlights do not include all the information needed to use TEPEZZA ® safely and effectively. See full prescribing information for TEPEZZA. TEPEZZA (teprotumumab-trbw) for injection, for intravenous use Initial U.S. Approval: 202020251110
3e6c54a1-cefd-4a5b-a855-ab9f268b6cceTepezza 500 MG InjectionSY17These highlights do not include all the information needed to use TEPEZZA ® safely and effectively. See full prescribing information for TEPEZZA. TEPEZZA (teprotumumab-trbw) for injection, for intravenous use Initial U.S. Approval: 202020251110
3e6c54a1-cefd-4a5b-a855-ab9f268b6cceTEPEZZA 500 MG InjectionPSN17These highlights do not include all the information needed to use TEPEZZA ® safely and effectively. See full prescribing information for TEPEZZA. TEPEZZA (teprotumumab-trbw) for injection, for intravenous use Initial U.S. Approval: 202020251110