What this pack is
HYZAAR is the brand name in this record; losartan potassium and hydrochlorothiazide is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
HYZAARGeneric namelosartan potassium and hydrochlorothiazide
How this medicine works
The current label explains that losartan and its active metabolite block angiotensin II binding at the AT1 receptor, reducing vasoconstrictor and aldosterone-related effects, while hydrochlorothiazide reduces sodium and chloride reabsorption so more sodium and water leave in urine. Combining both paths in one tablet does not let the site split or rebuild an individual's regimen from a blood-pressure number.
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
- HYZAAR
- Generic name
- losartan potassium and hydrochlorothiazide
- Dosage-form class
- Fixed two-ingredient losartan potassium/hydrochlorothiazide film-coated oral tablets: 50/12.5 mg, 100/12.5 mg and 100/25 mg; each pair describes two ingredients in 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.
3 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 (prescribing information revised Jun 2025; verified 29 Aug 2026)
Losartan potassium 50 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle
- Product code
- NDC 78206-139-01
- Form and route
- HYZAAR losartan potassium/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- losartan potassium
- 50 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 12.5 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 30 tablets per bottle
- Labelled appearance
- yellow · oval film-coated tablet, about 11 mm; unscored · imprint 717Unscored; do not infer permission to split it
United States label · Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)
Losartan potassium 100 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle
- Product code
- NDC 78206-140-01
- Form and route
- HYZAAR losartan potassium/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- losartan potassium
- 100 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 12.5 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 30 tablets per bottle
- Labelled appearance
- white · oval film-coated tablet, about 13 mm; unscored · imprint 745Unscored; do not infer permission to split it
United States label · Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)
Losartan potassium 100 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle
- Product code
- NDC 78206-141-01
- Form and route
- HYZAAR losartan potassium/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- losartan potassium
- 100 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 25 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 30 tablets per bottle
- Labelled appearance
- light yellow · oval film-coated tablet, about 16 mm; unscored · imprint 747Unscored; do not infer permission to split it
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
HYZAAR label reading: the two numbers are two ingredients, not a splitting or dose formula
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 HYZAAR tablet contains fixed amounts of losartan potassium and hydrochlorothiazide. For example, 50/12.5 mg means 50 mg and 12.5 mg of the two ingredients in one tablet; it is not a half-tablet cue, a two-tablet cue or a 62.5 mg total that can be directly converted to another product.
- Check the active ingredients on every pack. COZAAR is losartan alone, MICROZIDE is hydrochlorothiazide alone, and AVALIDE and EXFORGE HCT also contain hydrochlorothiazide. If any appear together with HYZAAR, do not remove or add a pack yourself; a pharmacist or prescriber must use the complete prescriptions to determine whether use is intentional or duplicative.
- Dizziness, fainting, marked weakness, thirst, clearly reduced urine, persistent vomiting or diarrhoea, muscle weakness or cramps, or an abnormal heartbeat may accompany changes in blood pressure, fluid balance, kidney function or electrolytes. Use local emergency services for severe or sudden symptoms or altered consciousness.
- Do not use potassium supplements or potassium-containing salt substitutes without professional review. Lithium, NSAID pain medicines, other medicines affecting the renin-angiotensin system and other diuretic or blood-pressure medicines all require review against the complete medicine list.
- Sudden eye pain, rapidly reduced vision or marked blurred vision requires prompt medical assessment. Swelling of the face, lips, tongue or throat, breathing difficulty or fainting requires local emergency services.
- 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 use the site to arrange stopping or switching.
- The label advises sun protection and skin screening as clinically directed for hydrochlorothiazide users. This does not mean skin cancer will occur and is not a reason to stop treatment independently.
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 · 2
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. HYZAAR losartan potassium/hydrochlorothiazide public label (Organon; prescribing information revised Jun 2025) ↗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 · 2026-08-29FDA Orange Book current data: HYZAAR, NDA 020387; all three oral-tablet strengths are prescription RLD products ↗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 HYZAAR (losartan potassium and hydrochlorothiazide). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
HYZAAR is the brand in this record and losartan potassium and hydrochlorothiazide is the active-ingredient name. Check both with the dosage form (Fixed two-ingredient losartan potassium/hydrochlorothiazide film-coated oral tablets: 50/12.5 mg, 100/12.5 mg and 100/25 mg; each pair describes two ingredients in 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. HYZAAR losartan potassium/hydrochlorothiazide public label (Organon; prescribing information revised Jun 2025) ↗Current regulatory record · reviewed 2026-08-29
- FDA Orange Book current data: HYZAAR, NDA 020387; all three oral-tablet strengths are prescription RLD products ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How the two ingredients work together: one blocks angiotensin II signalling and one increases sodium and water excretion
- The losartan component can affect potassium and kidney function; the hydrochlorothiazide component can cause low potassium, sodium or magnesium and affect urate, glucose, lipids and calcium. The word 'blood pressure' alone must not replace symptoms, laboratory review and the complete medicine list.
- 50/12.5, 100/12.5 and 100/25 are three complete product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, split, make-up use or alternation plan.
- Older adults and people with kidney or liver impairment, diabetes, gout or volume depletion particularly need professional review using the actual packs and monitoring results; the site does not generate a regimen from age or laboratory values.
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. HYZAAR losartan potassium/hydrochlorothiazide public label (Organon; prescribing information revised Jun 2025) ↗Current regulatory record · reviewed 2026-08-29
- FDA Orange Book current data: HYZAAR, NDA 020387; all three oral-tablet strengths are prescription RLD products ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
HYZAARlosartan potassium and hydrochlorothiazide
This page includes an exact current U.S. public-label package panel for HYZAAR, 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 approval of 50/12.5 mg
Current Orange Book data list this strength as NDA 020387 product 001 and a prescription RLD.
FDA Orange Book current data: HYZAAR, NDA 020387; all three oral-tablet strengths are prescription RLD products ↗Approval of 100/25 mg
Current Orange Book data list this strength as product 002 and a prescription RLD.
FDA Orange Book current data: HYZAAR, NDA 020387; all three oral-tablet strengths are prescription RLD products ↗Approval of 100/12.5 mg
Current Orange Book data list this strength as product 003 and a prescription RLD.
FDA Orange Book current data: HYZAAR, NDA 020387; all three oral-tablet strengths are prescription RLD products ↗Current public prescribing-information revision
The current DailyMed page retains the three strengths, appearances, packs, boxed warning, interactions and other label-reading routes.
DailyMed (NLM): current U.S. HYZAAR losartan potassium/hydrochlorothiazide public label (Organon; prescribing information revised Jun 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Current DailyMed brand label; all three strengths are listed as prescription RLD products in the Orange BookThis page displays three 30-tablet bottle panels; the label does not establish stock at a particular pharmacy or purchasing eligibility.
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 50/12.5 mg mean splitting the tablet in half?
No. It means one tablet contains losartan potassium 50 mg and hydrochlorothiazide 12.5 mg. The label lists these tablets as unscored, and the site does not convert the milligram pair into splitting or an individual tablet count.
Can COZAAR or MICROZIDE be taken in addition to HYZAAR?
The website cannot decide for an individual. HYZAAR already contains losartan and hydrochlorothiazide, so an additional single-ingredient product may be duplicative or may be intentionally prescribed; only the exact prescriptions, packs and complete medicine list can establish that. Do not add or stop a pack yourself.
Can the three HYZAAR products be substituted by colour?
No. Yellow 717, white 745 and light-yellow 747 correspond to different two-ingredient strengths and NDCs. Colour is only an appearance clue and does not establish authenticity, suitability or interchangeability.
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.