FDA.reportPublic FDA data

Gemtesa 75 MG Oral Tablet

RxCUI
2472321
RxNorm name
Gemtesa 75 MG Oral Tablet
Display name
Gemtesa 75 MG Oral Tablet
Full name
Gemtesa 75 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

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
GEMTESAVIBEGRONSumitomo Pharma America, Inc.25f21d25-14f8-4fda-91f6-7aa8b68aa1c82025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 2472321

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
25f21d25-14f8-4fda-91f6-7aa8b68aa1c8GEMTESA 75 MG Once-Daily Oral Tablet [PSN] · vibegron 75 MG Oral Tablet [Gemtesa] [SBD] · Gemtesa 75 MG Oral Tablet [SY]312These highlights do not include all the information needed to use GEMTESA ® safely and effectively. See full prescribing information for GEMTESA. GEMTESA (vibegron) tablets, for oral use Initial U.S. Approval: 202020250401