FDA.reportPublic FDA data

amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]

RxCUI
999971
RxNorm name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]
Display name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]
Full name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

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
TribenzorOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.2f56d0bc-236b-41a0-9fc0-21cdfea8d8902023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 999971

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
2f56d0bc-236b-41a0-9fc0-21cdfea8d890TRIBENZOR 20 MG / 5 MG / 12.5 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor] [SBD] · Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet [Tribenzor] [SY] · Tribenzor 20/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral Tablet [SY]43These highlights do not include all the information needed to use TRIBENZOR safely and effectively. See full prescribing information for TRIBENZOR. TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 201020230712