What this pack is
Exforge HCT is the brand name in this record; amlodipine, valsartan and hydrochlorothiazide is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
Exforge HCTGeneric nameamlodipine, valsartan and hydrochlorothiazide
How this medicine works
The current label describes EXFORGE HCT as a fixed combination of the dihydropyridine calcium-channel blocker amlodipine, the angiotensin-II receptor blocker valsartan and the thiazide diuretic hydrochlorothiazide. Mechanism helps explain why complete-list review matters; it does not predict an individual's blood pressure, kidney function, electrolytes, response, amount or whether a switch is suitable.
Read source: United States ↗reviewed 2026-08-20More 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
- Exforge HCT
- Generic name
- amlodipine, valsartan and hydrochlorothiazide
- Dosage-form class
- Oral film-coated tablets: amlodipine/valsartan/hydrochlorothiazide 5 mg/160 mg/12.5 mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg (as listed in the current U.S. label)
- 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.
Each panel identifies three labelled ingredients in one tablet. A shared ingredient, one or two numbers, or a similar EXFORGE name never establishes self-combination, substitution, alternation or an individual tablet count.
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 · DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025
Per tablet: amlodipine 5 mg + valsartan 160 mg + hydrochlorothiazide 12.5 mg; 30-tablet bottle
- Product code
- NDC 0078-0559-15
- Form and route
- amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet · oral
- Container
- child-resistant bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- amlodipine
- 5 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- valsartan
- 160 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- hydrochlorothiazide
- 12.5 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- Package
- 30 tablets per bottle
United States label · DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025
Per tablet: amlodipine 5 mg + valsartan 160 mg + hydrochlorothiazide 25 mg; 30-tablet bottle
- Product code
- NDC 0078-0560-15
- Form and route
- amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet · oral
- Container
- child-resistant bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- amlodipine
- 5 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- valsartan
- 160 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- hydrochlorothiazide
- 25 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- Package
- 30 tablets per bottle
United States label · DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025
Per tablet: amlodipine 10 mg + valsartan 160 mg + hydrochlorothiazide 12.5 mg; 30-tablet bottle
- Product code
- NDC 0078-0561-15
- Form and route
- amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet · oral
- Container
- child-resistant bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- amlodipine
- 10 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- valsartan
- 160 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- hydrochlorothiazide
- 12.5 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- Package
- 30 tablets per bottle
United States label · DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025
Per tablet: amlodipine 10 mg + valsartan 160 mg + hydrochlorothiazide 25 mg; 30-tablet bottle
- Product code
- NDC 0078-0562-15
- Form and route
- amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet · oral
- Container
- child-resistant bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- amlodipine
- 10 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- valsartan
- 160 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- hydrochlorothiazide
- 25 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- Package
- 30 tablets per bottle
United States label · DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025
Per tablet: amlodipine 10 mg + valsartan 320 mg + hydrochlorothiazide 25 mg; 30-tablet bottle
- Product code
- NDC 0078-0563-15
- Form and route
- amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet · oral
- Container
- child-resistant bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- amlodipine
- 10 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- valsartan
- 320 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- hydrochlorothiazide
- 25 mglabelled amount per tablet; not an individual's tablet count or adjustment rule
- Package
- 30 tablets per bottle
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
EXFORGE HCT label reading: 5/160/12.5 identifies three ingredients in one tablet
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.
This module uses the current U.S. public label to check EXFORGE HCT, amlodipine, valsartan, hydrochlorothiazide, the complete three-number marking, oral film-coated tablet and NDC. It does not decide whether someone needs all three ingredients, a tablet count, co-use with another antihypertensive/diuretic or an adjustment.
- 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25 and 10/320/25 mg are complete three-ingredient markings per tablet. Do not read only one number, derive a personal tablet count, adjust an amount or self-assemble the product from single-ingredient and combination medicines.
- EXFORGE contains amlodipine and valsartan only; EXFORGE HCT also contains hydrochlorothiazide. Similar names or a shared amlodipine/valsartan ingredient do not establish self-combination, alternation or substitution.
- With another antihypertensive, diuretic, a product containing valsartan/losartan/irbesartan, pain medicine, salt substitute, supplement or multiple medicines, have the actual packs and complete list reviewed by a pharmacist or clinician. A webpage cannot turn a shared class or ingredient into an individual co-use conclusion.
- Pregnancy/planning pregnancy, fainting, marked dizziness, chest pain, breathing trouble, facial or throat swelling or another acute concern needs timely local clinical or urgent support; this page does not decide self-stopping, restarting or changing to another medicine.
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 · 2026-08-20
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 · 1
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. EXFORGE HCT amlodipine/valsartan/hydrochlorothiazide public label (Novartis; SPL v33) ↗reviewed 2026-08-20
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 Exforge HCT (amlodipine, valsartan and hydrochlorothiazide). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Exforge HCT is the brand in this record and amlodipine, valsartan and hydrochlorothiazide is the active-ingredient name. Check both with the dosage form (Oral film-coated tablets: amlodipine/valsartan/hydrochlorothiazide 5 mg/160 mg/12.5 mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg (as listed in the current U.S. label)) 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How three ingredients appear together: calcium-channel, angiotensin-II receptor and thiazide-diuretic pathways
- Three pathways do not mean another calcium-channel blocker, ARB, ACE inhibitor, diuretic or combination antihypertensive can be self-added. Any addition, stopping, alternation or substitution needs review by a professional with the complete list and history.
- Label terms involving volume status, kidney function, potassium/sodium or uric acid are cues for professional review, not grounds to change tablet count from a home blood-pressure reading, symptoms or online experience.
- A mechanism explanation cannot manage dehydration, severe low-blood-pressure-like symptoms, chest pain, allergy, pregnancy-related risk or complex polypharmacy. With an acute or serious concern, prioritise local medical support.
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.
SOURCE-TRACEABLE ARCHIVE
Exforge HCTamlodipine, valsartan and hydrochlorothiazide
This page includes an exact current U.S. public-label package panel for Exforge HCT, 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
NDA 022314 original application approval
The FDA Drugs@FDA public record lists EXFORGE HCT original application (ORIG 1) as approved on 30 Apr 2009. This U.S. regulatory node does not establish approval, supply or individual suitability in another market.
FDA: EXFORGE HCT NDA 022314 original approval letter (2009-04-30) ↗Initial U.S. approval year listed in the current label
The current EXFORGE HCT label lists Initial U.S. Approval: 2009; it does not establish product status in another market.
DailyMed: current EXFORGE HCT public label, SPL v33 ↗Current SPL v33 updated date
The current DailyMed label's updated date is 12 Dec 2025; it remains separate from publication.
DailyMed: current EXFORGE HCT public label, SPL v33 ↗DailyMed published current SPL v33
DailyMed lists 15 Dec 2025 as the current v33 Published Date; this page does not interpret it as individual-treatment advice.
DailyMed: current EXFORGE HCT public label, SPL v33 ↗
MARKET SCOPE
Market-record boundary
United States
Current three-ingredient label and one exact package panel linkedThe image corresponds only to the 5 mg/160 mg/12.5 mg, NDC 0078-0559-15, 30-tablet panel; it does not establish actual marketing, stock or another-strength status.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. label.
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
Can 5/160/12.5 mg be read as just one of its three numbers?
No. It identifies the three labelled ingredient amounts in this exact fixed-combination tablet. The page does not turn it into an individual tablet count, adjustment or conversion to single-ingredient medicines.
Can EXFORGE and EXFORGE HCT be self-switched?
No. EXFORGE HCT additionally contains hydrochlorothiazide and is a three-ingredient product. Similar brand names do not establish self-interchangeability; take the actual packs and complete medicine list to a pharmacist or prescribing team.
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.