What this pack is
TRIBENZOR is the brand name in this record; olmesartan medoxomil, amlodipine and hydrochlorothiazide is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
TRIBENZORGeneric nameolmesartan medoxomil, amlodipine and hydrochlorothiazide
How this medicine works
The current label explains that olmesartan blocks angiotensin II activity at the AT1 receptor, amlodipine supports peripheral arterial vasodilation, and hydrochlorothiazide affects renal-tubular electrolyte reabsorption and increases sodium and chloride excretion. Combining three pathways in one tablet does not let the site split or rebuild an individual's regimen from blood pressure, urine output or a laboratory result.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- TRIBENZOR
- Generic name
- olmesartan medoxomil, amlodipine and hydrochlorothiazide
- Dosage-form class
- Olmesartan medoxomil/amlodipine/hydrochlorothiazide fixed three-ingredient film-coated oral tablets: 20/5/12.5, 40/5/12.5, 40/5/25, 40/10/12.5 and 40/10/25 mg; the three pack-order numbers belong to one tablet
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
5 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)
Olmesartan medoxomil 20 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle
- Product code
- NDC 0713-0874-30
- Form and route
- TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet · oral (fixed three-ingredient product-identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- olmesartan medoxomil
- 20 mgfirst ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction
- amlodipine
- 5 mgsecond ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine
- hydrochlorothiazide
- 12.5 mgthird ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- orange white · round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it · imprint C51Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)
Olmesartan medoxomil 40 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle
- Product code
- NDC 0713-0875-30
- Form and route
- TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet · oral (fixed three-ingredient product-identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- olmesartan medoxomil
- 40 mgfirst ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction
- amlodipine
- 5 mgsecond ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine
- hydrochlorothiazide
- 12.5 mgthird ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- light yellow · round, unscored film-coated tablet, approximately 10 mm; an unscored tablet does not establish permission to split or crush it · imprint C53Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)
Olmesartan medoxomil 40 mg plus amlodipine 5 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle
- Product code
- NDC 0713-0876-30
- Form and route
- TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet · oral (fixed three-ingredient product-identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- olmesartan medoxomil
- 40 mgfirst ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction
- amlodipine
- 5 mgsecond ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine
- hydrochlorothiazide
- 25 mgthird ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- light yellow · oval, unscored film-coated tablet, approximately 15 mm; an unscored tablet does not establish permission to split or crush it · imprint C54Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)
Olmesartan medoxomil 40 mg plus amlodipine 10 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle
- Product code
- NDC 0713-0877-30
- Form and route
- TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet · oral (fixed three-ingredient product-identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- olmesartan medoxomil
- 40 mgfirst ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction
- amlodipine
- 10 mgsecond ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine
- hydrochlorothiazide
- 12.5 mgthird ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- grayish red · round, unscored film-coated tablet, approximately 10 mm; an unscored tablet does not establish permission to split or crush it · imprint C55Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)
Olmesartan medoxomil 40 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle
- Product code
- NDC 0713-0878-30
- Form and route
- TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet · oral (fixed three-ingredient product-identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- olmesartan medoxomil
- 40 mgfirst ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction
- amlodipine
- 10 mgsecond ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine
- hydrochlorothiazide
- 25 mgthird ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- grayish red · oval, unscored film-coated tablet, approximately 15 mm; an unscored tablet does not establish permission to split or crush it · imprint C57Unscored in this labelled presentation
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
TRIBENZOR label reading: one tablet already contains three blood-pressure ingredients; first check duplicate olmesartan, amlodipine and hydrochlorothiazide
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Each TRIBENZOR tablet contains fixed amounts of olmesartan medoxomil, amlodipine and hydrochlorothiazide. For example, 40/10/25 mg states the labelled amount of each ingredient in one tablet; it is not three tablets, a splitting cue or a sum that can be directly converted with single- or dual-ingredient products. The current label also states that this fixed combination is not indicated for initial hypertension therapy; that is not a website decision to start, stop or switch an individual's medicine.
- Read the active ingredients on every pack. AZOR already contains olmesartan and amlodipine; BENICAR, NORVASC and MICROZIDE are single-ingredient products that may duplicate one component. BENICAR HCT, EXFORGE HCT, HYZAAR, DIOVAN HCT, ZESTORETIC and AVALIDE may also share one or more ingredients. If they appear together, do not add or remove a pack yourself; a pharmacist or prescriber must review the complete prescriptions.
- The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or arrange stopping or switching independently.
- Older or frail adults with marked dizziness, fainting, a fall, reduced urine, or persistent vomiting or diarrhoea with dehydration signs should contact the care team promptly; use local emergency services for severe or sudden symptoms. The three ingredients jointly make blood pressure, kidney function, electrolytes and fluid status relevant; the site does not generate a regimen from age or one reading.
- Severe, persistent chronic diarrhoea with substantial weight loss may relate to the labelled sprue-like enteropathy, even after months or years of use, and warrants prompt contact with the care team. Use local emergency services for dehydration, fainting, altered consciousness or inability to take fluids.
- Sudden eye pain or reduced vision falls within the hydrochlorothiazide label warning for acute myopia/secondary angle-closure glaucoma and needs immediate medical attention. Do not wait for photo identification or use the site for a self-directed stopping or switching plan.
- The label associates hydrochlorothiazide with increased non-melanoma skin-cancer risk and advises sun protection and regular skin screening. This does not let the site diagnose a skin photograph; contact a professional for a new, changing or non-healing lesion.
- The label contraindicates aliskiren coadministration in patients with diabetes. Other RAS medicines, NSAIDs, lithium, potassium supplements or salt substitutes, colesevelam, and amlodipine with simvastatin (the label states a 20 mg/day limit) require exact-product and full-list review. The site does not change an individual's dose or arrange an interval.
- All five tablets are film-coated and unscored; round or oval shape, colour, imprint and NDC are product-identity clues only. An unscored tablet does not permit self-splitting, crushing or colour-based switching.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide public label (updated 12 Jul 2023) ↗Current regulatory record · reviewed 2026-08-29
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29Current FDA Orange Book data: TRIBENZOR, NDA 200175; all five oral-tablet strengths listed as prescription RLD products, with 40/10/25 mg also listed as the RS ↗reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Drugs@FDA official search entry: TRIBENZOR NDA 200175 original approval and application records ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about TRIBENZOR (olmesartan medoxomil, amlodipine and hydrochlorothiazide). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
TRIBENZOR is the brand in this record and olmesartan medoxomil, amlodipine and hydrochlorothiazide is the active-ingredient name. Check both with the dosage form (Olmesartan medoxomil/amlodipine/hydrochlorothiazide fixed three-ingredient film-coated oral tablets: 20/5/12.5, 40/5/12.5, 40/5/25, 40/10/12.5 and 40/10/25 mg; the three pack-order numbers belong to one tablet) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide public label (updated 12 Jul 2023) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: TRIBENZOR, NDA 200175; all five oral-tablet strengths listed as prescription RLD products, with 40/10/25 mg also listed as the RS ↗reviewed 2026-08-29
- FDA Drugs@FDA official search entry: TRIBENZOR NDA 200175 original approval and application records ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How three ingredients work together: ARB, calcium-channel blocker and thiazide-diuretic pathways
- A shared blood-pressure purpose does not make single-, dual- and triple-ingredient products self-combinable or convertible. The three ingredients make review of the complete medicine list, blood pressure, kidney function, electrolytes, fluid status and interactions especially important.
- The pack orders its three numbers as olmesartan medoxomil/amlodipine/hydrochlorothiazide, while Orange Book ingredient and strength fields follow that dataset's order. Read the ingredient names with the numbers; do not mechanically map the first number to the first ingredient in another list.
- A mechanism page cannot manage sudden chest pain, fainting, severe breathing difficulty, eye pain/reduced vision, severe dehydration, allergy or another acute severe problem. Use local medical support rather than self-adjusting from mechanism text.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide public label (updated 12 Jul 2023) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: TRIBENZOR, NDA 200175; all five oral-tablet strengths listed as prescription RLD products, with 40/10/25 mg also listed as the RS ↗reviewed 2026-08-29
- FDA Drugs@FDA official search entry: TRIBENZOR NDA 200175 original approval and application records ↗reviewed 2026-08-29
- FDA: TRIBENZOR NDA 200175 original approval letter (23 Jul 2010) ↗reviewed 2026-08-29
- FDA: TRIBENZOR NDA 200175 original review material (505 (b)(2), 2010) ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
TRIBENZORolmesartan medoxomil, amlodipine and hydrochlorothiazide
This page includes an exact current U.S. public-label package panel for TRIBENZOR, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Original TRIBENZOR approval
The FDA approval letter and current Orange Book data record five fixed three-ingredient strengths under NDA 200175.
FDA: TRIBENZOR NDA 200175 original approval letter (23 Jul 2010) ↗Current label marketing-start date for five NDCs
The current DailyMed page lists 1 Sep 2022 as the marketing-start date for all five 30-tablet bottle NDCs and no end date; this is not real-time stock evidence.
DailyMed (NLM): current U.S. TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide public label (updated 12 Jul 2023) ↗Current public label page updated
The current DailyMed page lists five strengths, five exact 30-tablet bottle panels, appearance and enlarged safety information.
DailyMed (NLM): current U.S. TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide public label (updated 12 Jul 2023) ↗Current Orange Book identity reviewed
Current data list all five strengths as prescription RLD products and 40/10/25 mg as the RS.
Current FDA Orange Book data: TRIBENZOR, NDA 200175; all five oral-tablet strengths listed as prescription RLD products, with 40/10/25 mg also listed as the RS ↗
MARKET SCOPE
Market-record boundary
United States
Five prescription RLD strengths; 40/10/25 mg also RS; five current-label NDCs have no marketing end dateThese official records support product-identity review; they do not establish real-time pharmacy stock, purchasing eligibility or interchangeability.
Mainland China and other markets
Current market record not establishedNo local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or milligram numbers.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does 40/10/25 mg mean three tablets?
No. It means one tablet contains olmesartan medoxomil 40 mg, amlodipine 10 mg and hydrochlorothiazide 25 mg. The site does not convert the three numbers into splitting, crushing or an individual tablet count.
Can AZOR, NORVASC or a diuretic be taken in addition to TRIBENZOR?
The site cannot decide for an individual. TRIBENZOR already contains olmesartan, amlodipine and hydrochlorothiazide, so another shared-ingredient product may be duplicative or intentionally prescribed. Only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself.
Why can Orange Book show the numbers in a different order?
The pack orders olmesartan medoxomil/amlodipine/hydrochlorothiazide, while current Orange Book data list amlodipine/hydrochlorothiazide/olmesartan medoxomil and order strengths accordingly. Read ingredient names with both lists rather than comparing number positions alone.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.