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Prescription medicine

Chlorthalidone Brand names: Hemiclor, Thalitone; first approved as Hygroton

Chlorthalidone (Hygroton) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.0743 per chlorthalidone 25 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $0.957 per Hemiclor 12.5 mg tablet.

  • Generic listed

Check it at the source: the chlorthalidone FDA label on DailyMed (effective August 5, 2026, Macleods Pharmaceuticals Limited); the NDA 12283 record on Drugs@FDA; every chlorthalidone label on DailyMed.

Highlights of the record

FDA label of August 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

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.

Forms and strengths

  • 12.5 mg
  • 15 mg
  • 25 mg
  • 50 mg

Tablet.

On the market

Earliest approval on file
April 7, 1960 Hygroton, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
47 first February 26, 1981; 18 with a marketed status in Drugs@FDA
Labelers listed (NDC)
38 of which 36 under generic applications, 2 under brand applications, repackagers included
Last listed patent
September 4, 2045 Hemiclor tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$0.0743 per tablet Chlorthalidone 25 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
5 since 2013 0 Class I among all firms' recalls; latest September 3, 2026; 2 more by firms not listed as its makers
FAERS reports
11,545 through July 30, 2026

What is chlorthalidone used for?

From the label: indications and usage

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. […]

Conditions named in the indications of chlorthalidone's FDA labels, with every medicine labeled for each:

From other chlorthalidone labels

High blood pressure: INDICATIONS AND USAGE 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.

Edema (fluid retention): 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).

FDA pharmacologic class: Thiazide-like Diuretic.

Source: FDA drug label (Chlorthalidone), Macleods Pharmaceuticals Limited, effective August 5, 2026 (SPL set 5de362df-8fb9-4421-864c-7ea06339d6e7), via openFDA; the full label on DailyMed

Is there a generic for chlorthalidone (Hygroton)?

The FDA approved the first generic chlorthalidone on February 26, 1981. 47 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists chlorthalidone from 36 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Hygroton tablets; a patent listed only for Hemiclor tablets runs to September 4, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 1960 earliest approval on file
  • 1981 first generic approved
  • 2045 last listed patent
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for chlorthalidone (Hygroton)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0743 per Chlorthalidone 25 mg tablet, down 12% from $0.0847 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Chlorthalidone 25 mg tablet (generic)
  • Hemiclor 12.5 mg tablet (brand)
$0.957
$0.0703
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Chlorthalidone 25 mg tabletGeneric$0.0743 per tablet$2.23-12%
Chlorthalidone 50 mg tabletGeneric$0.122 per tablet$3.65-3%
Hemiclor 12.5 mg tabletBrand$0.957 per tablet$28.71+0.1%
Thalitone 15 mg tabletBrand$3.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$106.27-0.3%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has chlorthalidone been recalled?

The FDA's Enforcement Report lists 7 recalls naming chlorthalidone since 2013: 0 Class I (the most serious), 7 Class II, 0 Class III; 3 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of chlorthalidone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
September 3, 2026Class IIInventia Healthcare LimitedFailed Dissolution Specifications
June 5, 2026Class IIInventia Healthcare LimitedFailed Dissolution Specifications
May 9, 2025Class IIAvKAREFailed Dissolution Specifications
February 7, 2022Class IISUN PHARMACEUTICAL INDUSTRIES INCForeign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
January 26, 2022Class IICARDINAL HEALTHCARECGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup: CHLORTHALIDONE, Tablet, 50 mg may have potentially been mislabeled as the following drug: SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301 …
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup: CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg) may have potentially been mislabeled as the following drug: PROPRANOLOL HCL, Tablet, 5 mg …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the chlorthalidone label say about other medicines?

The chlorthalidone label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name chlorthalidone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Lithiumdrug interactionsLithium renal clearance is reduced by chlorthalidone, increasing the risk of lithium toxicity.

Check chlorthalidone against other medicines

Source: FDA drug label (Chlorthalidone), Macleods Pharmaceuticals Limited, effective August 5, 2026 (SPL set 5de362df-8fb9-4421-864c-7ea06339d6e7), via openFDA; the full label on DailyMed

What do FAERS reports show for chlorthalidone?

The FDA Adverse Event Reporting System holds 11,545 reports that list chlorthalidone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 690 are coded as a death and 3,715 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Fatigue (named in the label)908
  • Nausea (named in the label)741
  • Drug Ineffective (a use or a product term, not a reaction)736
  • Diarrhoea (named in the label)687
  • Dizziness (named in the label)589
  • Pain562
  • Off Label Use (a use or a product term, not a reaction)544
  • Headache (named in the label)542

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as chlorthalidone?

77 other medicines are given the same way (oral) and in the same FDA class as chlorthalidone or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
MetolazoneHigh blood pressure, Heart failure, Edema (fluid retention)19 labelers$0.233 per tablet 2.5 mg tabletNo current entry
IndapamideHigh blood pressure, Heart failure, Edema (fluid retention)8 labelers$0.109 per tablet 1.25 mg tabletNo current entry
Amlodipine and indapamide and telmisartanHigh blood pressurenone listedn/aNo current entry
MetoprololHigh blood pressure, Heart failure64 labelers$0.085 per tablet 100 mg tabletA presentation being discontinued
DiltiazemHigh blood pressure42 labelers$0.144 per capsule 24h ER(cd) 120 mg capsuleA presentation being discontinued
LisinoprilHigh blood pressure, Heart failure36 labelers$0.0254 per tablet 20 mg tabletNo current entry
PropranololHigh blood pressure38 labelers$0.0493 per tablet 20 mg tabletIn shortage
CarvedilolHigh blood pressure, Heart failure41 labelers$0.0179 per tablet 6.25 mg tabletNo current entry

Every medicine labeled for the same conditions as chlorthalidone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does chlorthalidone compare with medicines for the same use?

11 side-by-side pages set chlorthalidone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to chlorthalidone
77 medicines for the same use
Other thiazide-like diuretics
the pharmacologic class, with prices and generics
Chlorthalidone side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other