What this pack is
HYGROTON / chlorthalidone is the brand name in this record; chlorthalidone immediate-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
HYGROTON / chlorthalidoneGeneric namechlorthalidone immediate-release tablets
How this medicine works
FDA pharmacology review describes chlorthalidone as a thiazide-like, sulfonamide-derived diuretic acting through antagonism of the distal tubular sodium-chloride cotransporter. The mechanism helps explain fluid, electrolyte and blood-pressure effects but cannot determine individual suitability, tablet count, timing, potassium use or combination therapy.
Read source: United States ↗reviewed 2026-09-02More 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
- HYGROTON / chlorthalidone
- Source-scoped market brand names
- HYGROTON · United StatesHistorical regulator record ↗Historical originator/RLD under NDA 012283; discontinued, with FDA review stating that withdrawal was not for safety or efficacy reasons. This page does not display an original-brand pack.
- chlorthalidone · United StatesCurrent regulator record ↗Current Mylan generic label under ANDA 086831; 25/50 mg in 100- and 1000-tablet bottles. A regulatory label is not live stock.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- chlorthalidone immediate-release tablets
- Dosage-form class
- Chlorthalidone immediate-release oral tablets. Historical originator HYGROTON, the current Mylan generic, HEMICLOR 12.5 mg and chlorthalidone-containing combinations are separate regulatory products; a shared ingredient does not establish pack, strength, tablet-count or substitution conclusions.
- 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.
4 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 generic label (revised 2 Apr 2026)
25 mg chlorthalidone per tablet; 100-tablet bottle
- Product code
- NDC 0378-0222-01
- Form and route
- chlorthalidone immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- chlorthalidone
- 25 mglabelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic
- Package
- 100 tablets per bottle
- Labelled appearance
- light yellow · round immediate-release tablet · imprint M35Unscored; do not infer splitting permission
United States label · Current U.S. DailyMed generic label (revised 2 Apr 2026)
25 mg chlorthalidone per tablet; 1000-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 0378-0222-10
- Form and route
- chlorthalidone immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-02; actual marketing, stock and availability are not established.
- chlorthalidone
- 25 mglabelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic
- Package
- 1000 tablets per bottle
- Labelled appearance
- light yellow · round immediate-release tablet · imprint M35Unscored; do not infer splitting permission
United States label · Current U.S. DailyMed generic label (revised 2 Apr 2026)
50 mg chlorthalidone per tablet; 100-tablet bottle
- Product code
- NDC 0378-0213-01
- Form and route
- chlorthalidone immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- chlorthalidone
- 50 mglabelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic
- Package
- 100 tablets per bottle
- Labelled appearance
- light green · round immediate-release tablet · imprint M / 75Scored appearance; not permission to split it yourself
United States label · Current U.S. DailyMed generic label (revised 2 Apr 2026)
50 mg chlorthalidone per tablet; 1000-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 0378-0213-10
- Form and route
- chlorthalidone immediate-release oral tablet · oral
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-02; actual marketing, stock and availability are not established.
- chlorthalidone
- 50 mglabelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic
- Package
- 1000 tablets per bottle
- Labelled appearance
- light green · round immediate-release tablet · imprint M / 75Scored appearance; not permission to split it yourself
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
Chlorthalidone enlarged label: separate historical HYGROTON, the current generic, per-tablet mg and bottle count
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.
The 25 mg and 50 mg figures are chlorthalidone per tablet; 100/1000 Tablets are bottle counts. The 50 mg tablet is scored, but a score is an exact-product appearance feature—not automatic permission for anyone to split, change an amount or switch medicines.
- Diuresis can affect fluid and electrolytes. Thirst, dry mouth, weakness, somnolence, muscle pain/cramps, nausea, an abnormal heartbeat, or changes in awareness or gait require timely review with sodium, potassium, magnesium, kidney function and the complete medicine list. Use local emergency care for severe symptoms or fainting.
- Older age, reduced food or fluid intake, vomiting/diarrhoea, fever, or another blood-pressure/diuretic medicine can increase volume depletion, orthostatic dizziness, hypotension and falls. Do not self-stop, increase, reduce or alternate from home blood pressure or oedema alone.
- The label calls for attention to kidney function, liver disease, uric acid/gout, glucose and lipid changes. Anuria is contraindicated; severe kidney or liver disease requires treating-professional assessment, and the site does not generate a plan from laboratory values.
- Digoxin, lithium, an NSAID pain medicine, a corticosteroid, ACTH, another diuretic or blood-pressure medicine on the same list requires priority review of electrolytes, kidney function, blood pressure and concentration-related risk. Do not self-space or remove a pack.
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 · 2026-09-02
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. generic chlorthalidone 25/50 mg label and two 100-tablet bottle panels (Mylan/Viatris, Apr 2026) ↗Current regulatory record · reviewed 2026-09-02
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 HYGROTON / chlorthalidone (chlorthalidone immediate-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
HYGROTON / chlorthalidone is the brand in this record and chlorthalidone immediate-release tablets is the active-ingredient name. Check both with the dosage form (Chlorthalidone immediate-release oral tablets. Historical originator HYGROTON, the current Mylan generic, HEMICLOR 12.5 mg and chlorthalidone-containing combinations are separate regulatory products; a shared ingredient does not establish pack, strength, tablet-count or substitution conclusions.) 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 chlorthalidone causes diuresis and lowers pressure: reduced distal tubular sodium-chloride reabsorption does not make diuretics milligram-interchangeable
- Chlorthalidone, hydrochlorothiazide, indapamide, furosemide, spironolactone and eplerenone are not one medicine. A shared diuretic purpose does not establish milligram conversion, alternation or combination.
- A low-potassium risk does not mean everyone should self-supplement. Potassium, potassium-containing salt substitutes, an ACE inhibitor/ARB/ARNI or a potassium-sparing diuretic can change risk in the opposite direction and requires laboratory and full-list review.
- More urination, weight change or oedema change is not an individual regimen. Marked weakness, altered awareness, a fall, palpitations or inability to eat or drink in an older adult needs prompt treating-team review and emergency care when severe.
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. generic chlorthalidone 25/50 mg label and two 100-tablet bottle panels (Mylan/Viatris, Apr 2026) ↗Current regulatory record · reviewed 2026-09-02
- FDA: HYGROTON (chlorthalidone) NDA 012283 originator/RLD history and discontinuation boundary (NDA 218647 clinical-pharmacology review) ↗reviewed 2026-09-02
- FDA: chlorthalidone pharmacology and bridging review for HYGROTON NDA 012283 and Mylan ANDA 086831 (NDA 218647) ↗reviewed 2026-09-02
SOURCE-TRACEABLE ARCHIVE
HYGROTON / chlorthalidonechlorthalidone immediate-release tablets
This page includes an exact current U.S. public-label package panel for HYGROTON / chlorthalidone, 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
Initial U.S. approval of HYGROTON
FDA review records chlorthalidone's initial approval in 1960 and identifies HYGROTON NDA 012283 as the historical originator/RLD.
FDA: HYGROTON (chlorthalidone) NDA 012283 originator/RLD history and discontinuation boundary (NDA 218647 clinical-pharmacology review) ↗FDA review clarified the discontinued originator and reference-standard boundary
The review states that HYGROTON was discontinued for reasons other than safety or efficacy and identifies Mylan chlorthalidone 50 mg under ANDA 086831 as the reference standard.
FDA: HYGROTON (chlorthalidone) NDA 012283 originator/RLD history and discontinuation boundary (NDA 218647 clinical-pharmacology review) ↗Current Mylan generic label revision
Current 25/50 mg, 100/1000-tablet bottle text and two 100-tablet package panels are publicly readable.
DailyMed (NLM): current U.S. generic chlorthalidone 25/50 mg label and two 100-tablet bottle panels (Mylan/Viatris, Apr 2026) ↗
MARKET SCOPE
Market-record boundary
United States — HYGROTON
Historical originator/RLD; discontinuedNDA 012283; FDA review states that discontinuation was not for safety or efficacy reasons.
United States — Mylan generic
Current public generic labelANDA 086831; 25/50 mg in 100- and 1000-tablet bottles.
Markets outside the United States
Local brand, strength, pack and supply are not establishedCheck the local regulator, current label and pack in hand item by item.
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.
RECORD FAQ
Record questions
Is the pictured pack the original HYGROTON pack?
No. The images are current Mylan/Viatris generic 25 mg or 50 mg package labels. HYGROTON is shown only as the historical originator/RLD identity; the page does not present a generic image as original-brand appearance.
The 50 mg tablet is scored. Can it be halved to make 25 mg?
Not from a score or arithmetic alone. The 25 mg and 50 mg are distinct exact products, and splitting depends on the prescription, product label, uniformity, individual context and pharmacist review. The site records the score but does not issue splitting permission.
Can chlorthalidone, hydrochlorothiazide or furosemide be alternated or combined?
The site cannot make that decision. They are different medicines with different potency, duration, indications and electrolyte/kidney risks. Professional combination may exist, but duplication or harm is also possible; exact packs, laboratory results, blood pressure and the complete list require review.
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.