FDA.reportPublic FDA data

Tribenzor

Product NDC
0713-0875
11-digit product format
007130875
Labeler code
0713
Product ID
0713-0875_004953ba-fe11-03eb-e063-6394a90a638c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA200175
Marketing category
NDA
Marketing start
2022-09-01
Substance
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
5; 12.5; 40 mg/1; mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N200175-001TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;20MGTABLET / ORALABRLD2010-07-23
N200175-002TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;40MGTABLET / ORALABRLD2010-07-23
N200175-003TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;25MG;40MGTABLET / ORALABRLD2010-07-23
N200175-004TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;12.5MG;40MGTABLET / ORALABRLD2010-07-23
N200175-005TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;25MG;40MGTABLET / ORALABRLD, RS2010-07-23

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
N200175-001AB
N200175-002AB
N200175-003AB
N200175-004AB
N200175-005AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

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

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Tribenzor as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Tribenzor as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration. ( 5.2 ). Monitor renal function and potassium in susceptible patients Increased angina or myocardial infarction with calcium channel blockers may occur upon dosage initiation or increase ( 5.3 ). Observe for signs of fluid or electrolyte imbalance ( 5.6 ). Exacerbation or activation of systemic lupus erythematosus ( 5.8 ). Acute angle-closure glaucoma ( 5.9 ). Sprue-like enteropathy has been reported. Consider discontinuation of Tribenzor in cases where no other etiology is found ( 5.10 ). 5.1 Fetal Toxicity Olmesartan medoxomil. Tribenzor can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Tribenzor as soon as possible [ see Use in specific Populations ( 8.1 ]. Hydrochlorothiazide. Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations (8.1) ]. 5.2 Hypotension in Volume- or Salt-Depleted Patients Olmesartan medoxomil. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics) symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil. Initiate treatment with Tribenzor under close medical supervision. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Amlodipine. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.3 Increased Angina and /or Myocardial Infarction Amlodipine. Patients, particularly those with severe ...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Tribenzor In the controlled trial of Tribenzor, patients were randomized to Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/10/25 mg), olmesartan medoxomil/amlodipine 40/10 mg, olmesartan medoxomil/hydrochlorothiazide 40/25 mg, or amlodipine/hydrochlorothiazide 10/25 mg. Subjects who received triple combination therapy were treated between two and four weeks with one of the three dual combination therapies. Safety data from this study were obtained in 574 patients with hypertension who received Tribenzor for 8 weeks. The frequency of adverse reactions was similar between men and women, patients 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers. In contrast, high-dose olmesartan use in non-diabetic patients appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking other angiotensin receptor blockers. No differences were observed between the groups receiving lower doses of olmesartan compared to other angiotensin blockers or those receiving therapy for < 6 months. Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics. Amlodipine. The following post-marketing event has ...

adverse reactions table

Table 1Adverse ReactionOM40/ AML10/ HCTZ25 mg (N = 574) n (%) OM40/ AML10 mg (N = 596) n (%) OM40/ HCTZ25mg (N = 580) n (%) AML10/ HCTZ25 mg (N = 552) n (%) Edema peripheral44 (7.7)42 (7.0)6 (1.0)46 (8.3)Headache37 (6.4)42 (7.0)38 (6.6)33 (6.0)Fatigue24 (4.2)34 (5.7)31 (5.3)36 (6.5)Nasopharyngitis20 (3.5)11 (1.8)20 (3.4)16 (2.9)Muscle spasms18 (3.1)12 (2.0)14 (2.4)13 (2.4)Nausea17 (3.0)12 (2.0)22 (3.8)12 (2.2)Upper respiratory tract infection16 (2.8)26 (4.4)18 (3.1)14 (2.5)Diarrhea15 (2.6)14 (2.3)12 (2.1)9 (1.6)Urinary tract infection14 (2.4)8 (1.3)6 (1.0)7 (1.3)Joint swelling12 (2.1)17 (2.9)2 (0.3)16 (2.9)

Additional Listing Data#

Finished product
Yes
Brand name base
Tribenzor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL5 mg/1
AMLODIPINE BESYLATE12.5 mg/1
HYDROCHLOROTHIAZIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, 6M97XTV3HD, 0J48LPH2TH
Rxcui999967, 999971, 999986, 999990, 999991, 999995, 999996, 1000000, 1000001, 1000005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0875-30Tribenzor30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0875-30EA - Each0713-0875499d196a-a578-49a1-8edf-721d9a01208c12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0875TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20230713_2f56d0bc-236b-41a0-9fc0-21cdfea8d890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999967olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971TRIBENZOR 20 MG / 5 MG / 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990TRIBENZOR 40 MG / 10 MG / 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995TRIBENZOR 40 MG / 10 MG / 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000TRIBENZOR 40 MG / 5 MG / 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005TRIBENZOR 40 MG / 5 MG / 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999967amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999967amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999967Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971Tribenzor 20/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990Tribenzor 40/10/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995Tribenzor 40/10/25 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000Tribenzor 40/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005Tribenzor 40/5/25 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0875-300071308753030 TABLET, FILM COATED in 1 BOTTLE (0713-0875-30) 2022-09-010000-00-00NoNoCurrent