Quick answers
- What is Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide used for?
- The FDA-approved label (Tribenzor, Cosette Pharmaceuticals, Inc., July 12, 2023) says: “Tribenzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide have a boxed warning?
- Yes. The FDA label for Tribenzor has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?
- 9 companies list prescription products of Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide in the FDA NDC Directory, including Bryant Ranch Prepack, Camber Pharmaceuticals, Inc. and Par Health USA, LLC.
What Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tribenzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. …
— FDA label: Tribenzor, Cosette Pharmaceuticals, Inc., effective July 12, 2023. Read the full label on DailyMed →
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
13 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 43 in the FDA NDC Directory |
| Brand names | Tribenzor |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| amlodipine besylate 10 mg · hydrochlorothiazide 12.5 mg · olmesartan medoxomil 40 mg tablet, film coated | Generic | $1.11 per tablet |
| amlodipine besylate 10 mg · hydrochlorothiazide 25 mg · olmesartan medoxomil 40 mg tablet, film coated | Generic | $1.01 per tablet |
| amlodipine besylate 10 mg · hydrochlorothiazide 25 mg · olmesartan medoxomil 40 mg tablet, film coated | Brand: Tribenzor | $19.41 per tablet |
| amlodipine besylate 5 mg · hydrochlorothiazide 12.5 mg · olmesartan medoxomil 20 mg tablet, film coated | Generic | $0.8385 per tablet |
| amlodipine besylate 5 mg · hydrochlorothiazide 12.5 mg · olmesartan medoxomil 40 mg tablet, film coated | Generic | $1.07 per tablet |
| amlodipine besylate 5 mg · hydrochlorothiazide 12.5 mg · olmesartan medoxomil 40 mg tablet, film coated | Brand: Tribenzor | $19.54 per tablet |
| amlodipine besylate 5 mg · hydrochlorothiazide 25 mg · olmesartan medoxomil 40 mg tablet, film coated | Generic | $1.07 per tablet |
NADAC list of November 4, 2026; these prices took effect between July 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack7 products
- Camber Pharmaceuticals, Inc.5 products
- Par Health USA, LLC5 products
- Cosette Pharmaceuticals, Inc.5 products
- Teva Pharmaceuticals USA, Inc.5 products
- Macleods Pharmaceuticals Limited5 products
- Slate Run Pharmaceuticals, LLC5 products
- Micro Labs Limited5 products
- Remedyrepack Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA200175 TRIBENZOR | Cosette | July 23, 2010 | 19, latest October 2, 2020 2020: Labeling · 2020: Labeling · 2017: Labeling |
Generic approvals (6)
- ANDA206137Ph Health · October 26, 2016
- ANDA202491Teva Pharms USA · November 3, 2016
- ANDA210718Piramal · May 14, 2025
- ANDA207088Macleods Pharms · July 18, 2025
- ANDA209242Hetero Labs Ltd V · October 6, 2025
- ANDA207437Micro Labs · November 24, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 999967, 999971, 999986, 999990, 999991, 999995, 999996, 1000000, 1000001, 1000005 |
|---|---|
| SPL set ID of the quoted label | 2f56d0bc-236b-41a0-9fc0-21cdfea8d890 |
| FDA labels (SPL) | 13 |
| FDA applications | NDA200175, 6 ANDA |
| Active ingredients (FDA) | AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tribenzor, Cosette Pharmaceuticals, Inc., effective July 12, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →