HomeNDC LookupIngredientsChlorthalidone › 72189-0507-60
Chlorthalidone 25 mg Tablet, 60-count — NDC 72189-0507-60 package photo

Chlorthalidone 25 mg Tablet, 60-count

by Direct_Rx · 60 TABLET in 1 BOTTLE (72189-507-60)
NDC 72189-0507-60
🏷️ FDA NDC (as labeled) 72189-507-60 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Chlorthalidone (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 5, 2026 — Failed Dissolution Specifications (Inventia Healthcare Limited) · FDA recall D-0610-2026
Class II · May 9, 2025 — Failed Dissolution Specifications (AvKARE) · FDA recall D-0461-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72189-507-60
Product NDC 72189-507
11-digit billing NDC 72189050760
NCPDP billing unit EA — each (per item)
RxCUI 197499
UNII Q0MQD1073Q
Application # ANDA214129
SPL Set ID 03204a70-d53b-0e44-e063-6394a90a2aab
Established class (EPC) Thiazide-like Diuretic
Physiologic effect Increased Diuresis
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-17
Route ORAL
Dosage form TABLET
Substance CHLORTHALIDONE
GCN Seq No 008213
GCN 34982
HICL code 003662
Ingredient (HICL) Chlorthalidone
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1F
Therapeutic class — specific (HIC3) Thiazide And Related Diuretics
AHFS code 24:36.24.00
AHFS class Thiazide-Like Diuretics (24:36)
FDB label name CHLORTHALIDONE 25 MG TABLET
FDB brand name Chlorthalidone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-507-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0507-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Thiazide-like Diuretic class.

Pharmacologic class Thiazide-like Diuretic
Drug family (ATC) Sulfonamides, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerDirect_Rx
Application holderAJANTA PHARMA LTD
FDA applicationANDA214129 (ANDA)
Labeler code72189
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio352 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CHLORTHALIDONE 25 MG TABLET Ingredient Chlorthalidone
📖 What it is MedlinePlus · NLM

Chlorthalidone, a is used to treat high blood pressure and fluid retention. Chlorthalidone is in a class of medications called diuretics ('water pills'). It causes the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Chlorthalidone is a water pill — it helps your kidneys remove extra salt and fluid from your body. That lowers the pressure inside your blood vessels, which is why it's used for hi...
  • What exactly is chlorthalidone supposed to do for me?
  • Take it in the morning with food — that's the standard recommendation. Taking it in the morning means the increased urination it causes happens during the day while you're awake, r...
  • Should I take it in the morning or at night, and does it matter if I eat?
📖 Read our full Chlorthalidone guide →
8
Nutrient depletion considerations

Chlorthalidone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintC;25
Size6 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2420 $14.52 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorthalidone 25 mg 00378-0222-01 Mylan 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 00904-6900-04 Major 30 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 16714-0128-01 Northstar 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 27241-0216-01 Ajanta 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 29300-0333-01 Unichem 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 43598-0170-01 Dr. 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 43598-0719-01 Dr. 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 50268-0167-15 AvPAK 50 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 51079-0058-20 Mylan 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 60687-0317-01 American 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 62135-0505-30 Chartwell 30 tablets $0.084 AB Availability likely
Chlorthalidone Chlorthalidone 25 mg 62332-0676-31 Alembic 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 64980-0303-01 Rising 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 64980-0599-01 Rising 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 67877-0696-01 Ascend 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 68382-0970-01 Zydus 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 70756-0011-11 Lifestar 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 75834-0109-01 Nivagen 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 51224-0018-50 TAGI 100 tablets $0.087 AB FDA listed
Chlorthalidone 25 mg 59746-0760-01 JUBILANT 100 tablets $0.087 AB FDA listed
Chlorthalidone 25 mg 00904-7583-04 Major 30 tablets AB FDA listed
Chlorthalidone Chlorthalidone 25 mg 46708-0676-31 Alembic 100 tablets AB FDA listed
Chlorthalidone 25 mg 48433-0021-20 Safecor 100 tablets AB FDA listed
Chlorthalidone 25 mg 50090-5643-01 A-S 30 tablets AB FDA listed
Chlorthalidone 25 mg 50090-6126-01 A-S 30 tablets AB FDA listed
Chlorthalidone 25 mg 50090-6957-01 A-S 30 tablets AB FDA listed
Chlorthalidone 25 mg 50090-6958-00 A-S 90 tablets AB FDA listed
Chlorthalidone 25 mg 50090-7831-00 A-S 90 tablets AB FDA listed
Chlorthalidone 25 mg 51655-0526-26 Northwind 90 tablets AB FDA listed
Chlorthalidone 25 mg 51655-0790-26 Northwind 90 tablets AB FDA listed
Chlorthalidone 25 mg 51655-0992-52 Northwind 30 tablets AB FDA listed
Chlorthalidone 25 mg 55289-0067-30 PD-Rx 30 tablets AB FDA listed
Chlorthalidone 25 mg 57664-0648-18 Sun 1000 tablets AB FDA listed
Chlorthalidone 25 mg 60290-0004-01 Umedica 100 tablets AB FDA listed
Chlorthalidone 25 mg 63629-8761-01 Bryant 100 tablets AB FDA listed
Chlorthalidone 25 mg 65162-0247-03 Amneal 30 tablets AB FDA listed
Chlorthalidone 25 mg 68788-4053-03 Preferred 30 tablets AB FDA listed
Chlorthalidone 25 mg 68788-4077-03 Preferred 30 tablets AB FDA listed
Chlorthalidone 25 mg 68788-8294-09 Preferred 90 tablets AB FDA listed
Chlorthalidone 25 mg 70518-3718-00 REMEDYREPACK 30 tablets AB FDA listed
Chlorthalidone 25 mg 70518-3954-00 REMEDYREPACK 30 tablets AB Discontinued
Chlorthalidone 25 mg 70518-4578-00 REMEDYREPACK 30 tablets AB FDA listed
Chlorthalidone 25 mg 70771-1369-00 Zydus 1000 tablets AB FDA listed
Chlorthalidone 25 mg 71205-0592-30 Proficient 30 tablets AB FDA listed
Chlorthalidone 25 mg 71335-0906-01 Bryant 30 tablets AB FDA listed
Chlorthalidone 25 mg 71335-1829-01 Bryant 30 tablets AB FDA listed
Chlorthalidone 25 mg 71335-2072-01 Bryant 30 tablets AB FDA listed
Chlorthalidone 25 mg 71335-2223-01 Bryant 30 tablets AB FDA listed
Chlorthalidone 25 mg 71335-2269-01 Bryant 30 tablets AB FDA listed
Chlorthalidone 25 mg 71335-2935-01 Bryant 1000 tablets AB FDA listed
Chlorthalidone 25 mg 71335-3074-01 Bryant 30 tablets AB FDA listed
Chlorthalidone 25 mg 71335-3124-01 Bryant 30 tablets AB FDA listed
Chlorthalidone 25 mg 71610-0029-09 Aphena 9000 tablets AB FDA listed
Chlorthalidone 25 mg 71610-0472-30 Aphena 30 tablets AB FDA listed
Chlorthalidone 25 mg 71610-0682-16 Aphena 6000 tablets AB FDA listed
Chlorthalidone 25 mg 72162-2133-00 Bryant 1000 tablets AB FDA listed
Chlorthalidone 25 mg 72189-0356-60 Direct_Rx 60 tablets AB FDA listed
Chlorthalidone 25 mgthis 72189-0507-60 Direct_Rx 60 tablets AB FDA listed
Chlorthalidone 25 mg 72189-0644-60 Direct_Rx 60 tablets AB FDA listed
Chlorthalidone 25 mg 72789-0358-30 PD-Rx 30 tablets AB FDA listed
Thalitone 25 mg 70199-0001-01 Casper 100 tablets Discontinued
Chlorthalidone 25 mg 68788-4169-03 Preferred 30 tablets AB FDA listed
Chlorthalidone 25 mg 33342-0425-07 Macleods 30 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chlorthalidone — the program that covers self-administered drugs. 16 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chlorthalidone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.31M
Claims incl. refills
733.1K
Beneficiaries
591.5K
Spend / beneficiary
$19.13
Spend / claim
$15.43
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Chlorthalidone — the ingredient across all brands.

Top reported reactions

Nausea1,258
Fatigue1,063
Diarrhoea849
Dizziness758
Headache715
Pain697
Dyspnoea665

Age at onset

Child1
Adolescent5
Adult1,324
Elderly1,411

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,310 594
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0507-60 You're viewing this 60 TABLET in 1 BOTTLE (72189-507-60) 2023-08-17 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72189-507-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0507-60, written without dashes as 72189050760. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0507-60, the first segment (72189) is the labeler code FDA assigned to Direct_Rx; the middle segment (0507) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Direct_Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct_Rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read

Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.

Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women.

If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.

⏱️ Dosage and Administration ~1 min read

Therapy should be initiated with the lowest possible dose. This dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. A single dose given in the morning with food is recommended; divided daily doses are unnecessary.

Hypertension Initiation: Therapy, in most patients, should be initiated with a single daily dose of 25 mg. If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg. If additional control is required, the dosage of chlorthalidone may be increased to 100 mg once daily or a second antihypertensive drug (step 2 therapy) may be added.

Dosage above 100 mg daily usually does not increase effectiveness. Increases in serum uric acid and decreases in serum potassium are dose-related over the 25 mg/day to 100 mg/day range. Maintenance: Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response.

Effectiveness is well sustained during continued use. Edema Initiation: Adults, initially 50 to 100 mg daily, or 100 mg on alternate days. Some patients may require 150 to 200 mg at these intervals or up to 200 mg daily.

Dosages above this level, however, do not usually produce a greater response. Maintenance: Maintenance doses may often be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

Contraindications 9 words

Anuria. Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs.

⚠️ Warnings 110 words

Chlorthalidone should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to chlorthalidone.

However, systemic lupus erythematosus has not been reported following chlorthalidone administration.

🤒 Adverse Reactions 130 words

The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis. Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia.

Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis). Cardiovascular Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics.

Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence. Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 69 words

Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established.

There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

🧬 Clinical Pharmacology 219 words

Chlorthalidone is an oral diuretic with prolonged action (48 hours to 72 hours) and low toxicity. The major portion of the drug is excreted unchanged by the kidneys. The diuretic effect of the drug occurs in approximately 2.6 hours and continues for up to 72 hours.

The mean half-life following a 50 mg to 200 mg dose is 40 hours. In the first order of absorption, the elimination half-life is 53 hours following a 50 mg dose, and 60 hours following a 100 mg dose. Approximately 75 percent of the drug is bound to plasma proteins, 58 percent of the drug being bound to albumin.

This is caused by an increased affinity of the drug to erythrocyte carbonic anhydrase. Nonrenal routes of elimination have yet to be clarified. Data are not available regarding percentage of dose as unchanged drug and metabolites, concentration of the drug in body fluids, degree of uptake by a particular organ or in the fetus, or passage across the blood-brain barrier.

The drug produces copious diuresis with greatly increased excretion of sodium and chloride. At maximal therapeutic dosage, chlorthalidone is approximately equal in its diuretic effect to comparable maximal therapeutic doses of benzothiadiazine diuretics. The site of action appears to be the cortical diluting segment of the ascending limb of Henle’s loop of the nephron.

📦 How Supplied / Storage and Handling 101 words

Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of chlorthalidone, USP. The 25 mg tablets are white to off-white, round flat beveled edge, uncoated tablets debossed with 'C' on one side and '25' on other side. They are available as follows: NDC 72189-507-60 Bottles of 60 tablets with child-resistant closures The 50 mg tablets are white to off-white, round flat beveled edge, uncoated tablets with breakline on one side with notch on both side of periphery and debossed 'C' over '50' on other side.

They are available as follows: NDC 27241-217-01 Bottles of 100 tablets with child-resistant closures

📦 Storage and Handling 40 words

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 97 words

Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1-hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula: [structure] Molecular Formula: C14H11ClN2O4S Molecular weight: 338.77 Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol.

Chlorthalidone tablets, USP are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate Type A (potato), magnesium stearate.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.