FDA.reportPublic FDA data

amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]

RxCUI
1000000
RxNorm name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]
Display name
TRIBENZOR (Oral Pill)
Full name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]
Term type
SBD
Status
Active
Strength
5-12.5-40 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-24 12:25:13

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092010
Active start
092010
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
amlodipine besylate5 MG / 1 EACHamlodipineamlodipine
olmesartan medoxomil40 MG / 1 EACHolmesartanolmesartan medoxomil
hydrochlorothiazide12.5 MG / 1 EACHhydrochlorothiazidehydrochlorothiazide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
amlodipine17767
olmesartan321064
hydrochlorothiazide5487

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRamLODIPine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]1NAMES
RxNorm Nameamlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID2f56d0bc-236b-41a0-9fc0-21cdfea8d8901CODES
RxCUI10000001CODES
MMSL_CODEBD264191CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0713-0875-300713-0875Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDA200175

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2001750713-0875Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideNDACosette Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 6 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00713087530rxnav_ndcsyes
65597011507rxnav_historical
65597011510rxnav_historical
65597011530rxnav_historical
65597011570rxnav_historical
65597011590rxnav_historical

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
ndc (package): 0713-0875-30
ndc (product): 0713-0875
ndc11 (package): 00713087530
rxcui: 1000000

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 40 MG / 5 MG / 12.5 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor] [SBD] · Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor] [SY] · Tribenzor 40/5/12.5 (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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
2f56d0bc-236b-41a0-9fc0-21cdfea8d890These 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: 2010Cosette Pharmaceuticals, Inc.20230712
5562b3f5-8757-11de-8a39-0800200c9a66These 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: 2010Daiichi Sankyo, Inc.20220607
85760e7f-0d27-4b83-87cc-41b2c51741e1National Council for Prescription Drug Programs20120724
d895d1b4-9936-4774-84ca-1e614d4f1b53National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC09CAAngiotensin II receptor blockers (ARBs), plainATC1-4olmesartan medoxomil
ATCC08CADihydropyridine derivativesATC1-4amlodipine
ATCC03AAThiazides, plainATC1-4hydrochlorothiazide
FDASPLD004095DihydropyridinesCHEMhas_chemical_structureamlodipine
FDASPLD049971ThiazidesCHEMhas_chemical_structurehydrochlorothiazide
FDASPLN0000175561Angiotensin 2 Receptor BlockerEPChas_epcolmesartan
FDASPLN0000175566Calcium Channel BlockerEPChas_epcamlodipine
FDASPLN0000175421Dihydropyridine Calcium Channel BlockerEPChas_epcamlodipine
FDASPLN0000175419Thiazide DiureticEPChas_epchydrochlorothiazide
FDASPLN0000000070Angiotensin 2 Receptor AntagonistsMOAhas_moaolmesartan
FDASPLN0000000069Calcium Channel AntagonistsMOAhas_moaamlodipine
FDASPLN0000190114Cytochrome P450 3A InhibitorsMOAhas_moaamlodipine
FDASPLN0000175359Increased DiuresisPEhas_pehydrochlorothiazide
MEDRTD017311AmlodipineCHEMhas_ingredientamlodipine
MEDRTD006852HydrochlorothiazideCHEMhas_ingredienthydrochlorothiazide
MEDRTD007093ImidazolesCHEMhas_ingredientolmesartan
MEDRTD000068557Olmesartan MedoxomilCHEMhas_ingredientolmesartan medoxomil
MEDRTD013449SulfonamidesCHEMci_chemclasshydrochlorothiazide
MEDRTD013777TetrazolesCHEMhas_ingredientolmesartan
MEDRTD000788Angina Pectoris, VariantDISEASEmay_treatamlodipine
MEDRTD001002AnuriaDISEASEci_withhydrochlorothiazide
MEDRTD003324Coronary Artery DiseaseDISEASEmay_treatamlodipine
MEDRTD003928Diabetic NephropathiesDISEASEmay_treatolmesartan medoxomil
MEDRTD003928Diabetic NephropathiesDISEASEmay_treatolmesartan
MEDRTD004342Drug HypersensitivityDISEASEci_withamlodipine
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrochlorothiazide
MEDRTD004342Drug HypersensitivityDISEASEci_witholmesartan medoxomil
MEDRTD004342Drug HypersensitivityDISEASEci_witholmesartan
MEDRTD004487EdemaDISEASEmay_treathydrochlorothiazide
MEDRTD006333Heart FailureDISEASEmay_treathydrochlorothiazide
MEDRTD006333Heart FailureDISEASEmay_treatolmesartan
MEDRTD006333Heart FailureDISEASEmay_treatolmesartan medoxomil
MEDRTD006929HyperaldosteronismDISEASEci_witholmesartan
MEDRTD006929HyperaldosteronismDISEASEci_witholmesartan medoxomil
MEDRTD006973HypertensionDISEASEmay_treatolmesartan medoxomil
MEDRTD006973HypertensionDISEASEmay_treatolmesartan
MEDRTD006973HypertensionDISEASEmay_treathydrochlorothiazide
MEDRTD006973HypertensionDISEASEmay_treatamlodipine
MEDRTD007022HypotensionDISEASEci_witholmesartan
MEDRTD007022HypotensionDISEASEci_witholmesartan medoxomil
MEDRTD007022HypotensionDISEASEci_withamlodipine
MEDRTD009404Nephrotic SyndromeDISEASEmay_treathydrochlorothiazide
MEDRTD011247PregnancyDISEASEci_witholmesartan
MEDRTD011247PregnancyDISEASEci_witholmesartan medoxomil
MEDRTD011247PregnancyDISEASEci_withhydrochlorothiazide
MEDRTD051437Renal InsufficiencyDISEASEci_withhydrochlorothiazide
MEDRTD018487Ventricular Dysfunction, LeftDISEASEmay_treatolmesartan
MEDRTD018487Ventricular Dysfunction, LeftDISEASEmay_treatolmesartan medoxomil
MEDRTN0000000070Angiotensin 2 Receptor AntagonistsMOAhas_moaolmesartan
MEDRTN0000000070Angiotensin 2 Receptor AntagonistsMOAhas_moaolmesartan medoxomil
MEDRTN0000020065L-Calcium Channel Receptor AntagonistsMOAhas_moaamlodipine
MEDRTN0000181005Sodium Chloride Symporter InhibitorsMOAhas_moahydrochlorothiazide
MEDRTN0000008375Coronary Arterial VasodilationPEhas_peamlodipine
MEDRTN0000178477Decreased Blood PressurePEci_peamlodipine
MEDRTN0000178477Decreased Blood PressurePEhas_pehydrochlorothiazide
MEDRTN0000178477Decreased Blood PressurePEhas_peamlodipine
MEDRTN0000178477Decreased Blood PressurePEhas_peolmesartan
MEDRTN0000178477Decreased Blood PressurePEhas_peolmesartan medoxomil
MEDRTN0000008579Decreased Distal Tubule Ca++ ExcretionPEhas_pehydrochlorothiazide
MEDRTN0000008669Decreased Intravascular VolumePEhas_peolmesartan medoxomil
MEDRTN0000008669Decreased Intravascular VolumePEhas_peolmesartan
MEDRTN0000008669Decreased Intravascular VolumePEhas_pehydrochlorothiazide
MEDRTN0000008731Decreased Mineralocorticoid SecretionPEhas_peolmesartan
MEDRTN0000008731Decreased Mineralocorticoid SecretionPEhas_peolmesartan medoxomil
MEDRTN0000008859Decreased Renal K+ ExcretionPEhas_peolmesartan medoxomil
MEDRTN0000008859Decreased Renal K+ ExcretionPEhas_peolmesartan
MEDRTN0000009274Increased Distal Tubule Cl- ExcretionPEhas_pehydrochlorothiazide
MEDRTN0000009275Increased Distal Tubule H+ ExcretionPEhas_pehydrochlorothiazide
MEDRTN0000009277Increased Distal Tubule K+ ExcretionPEhas_pehydrochlorothiazide
MEDRTN0000009279Increased Distal Tubule Na+ ExcretionPEhas_pehydrochlorothiazide
MEDRTN0000175359Increased DiuresisPEhas_pehydrochlorothiazide
MEDRTN0000009553Increased Renal Na+ ExcretionPEhas_peolmesartan
MEDRTN0000009553Increased Renal Na+ ExcretionPEhas_peolmesartan medoxomil
MEDRTN0000009825Renal Arterial VasoconstrictionPEci_peolmesartan
MEDRTN0000009825Renal Arterial VasoconstrictionPEci_peolmesartan medoxomil
MEDRTN0000009826Renal Arterial VasodilationPEhas_peolmesartan medoxomil
MEDRTN0000009826Renal Arterial VasodilationPEhas_peolmesartan
MEDRTN0000009909VasodilationPEhas_pehydrochlorothiazide
MEDRTN0000000042Renal ExcretionPKhas_pkhydrochlorothiazide

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH5 MG / 12.5 MG / 40 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA200175
NAMESPrescribable SynonymTRIBENZOR 40 MG / 5 MG / 12.5 MG Oral Tablet
NAMESTallman SynonymamLODIPine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]
NAMESTallman SynonymamLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]
NAMESTallman SynonymTribenzor 40/5/12.5 (olmesartan medoxomil / amLODIPine (as amLODIPine besylate) / HCTZ) Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon