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)Rx2026-10-01

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
3e6c54a1-cefd-4a5b-a855-ab9f268b6cceTEPEZZA 500 MG Injection [PSN] · teprotumumab-trbw 500 MG Injection [Tepezza] [SBD] · Tepezza 500 MG Injection [SY]317These 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