FDA.reportPublic FDA data

nirogacestat 150 MG (equivalent to nirogacestat HBr 199.574 MG) Oral Tablet

RxCUI
2680366
RxNorm name
nirogacestat 150 MG (equivalent to nirogacestat HBr 199.574 MG) Oral Tablet
Display name
nirogacestat 150 MG (equivalent to nirogacestat HBr 199.574 MG) Oral Tablet
Full name
nirogacestat 150 MG (equivalent to nirogacestat HBr 199.574 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

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
OGSIVEONIROGACESTATSpringWorks Therapeutics, Inc.f172e6ff-3190-41b0-b95a-58a7ef9e9e1e2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 2680366

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
f172e6ff-3190-41b0-b95a-58a7ef9e9e1enirogacestat 150 MG Oral Tablet [PSN] · nirogacestat 150 MG Oral Tablet [SCD] · nirogacestat 150 MG (equivalent to nirogacestat HBr 199.574 MG) Oral Tablet [SY]314These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 202320260326