Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Chlorthalidone

Brand names: Thalitone, Hemiclor

Drug class: Thiazide-like Diuretic

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
5Recalls (FDA reports)
38Companies
1981First FDA approval on file

Quick answers

What is Chlorthalidone used for?
The FDA-approved label (Thalitone, Casper Pharma LLC, June 25, 2026) says: “THALITONE is a thiazide-like diuretic indicated: • For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • as adjunctive therapy in edema associated with heart failure, cirrhosis of the liver, and renal disease, including nephrotic syndrome. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Chlorthalidone have a boxed warning?
No. None of the 77 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Chlorthalidone?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Chlorthalidone been recalled?
FDA enforcement reports list 5 recalls of products of this medicine; the newest started September 3, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Chlorthalidone?
38 companies list prescription products of Chlorthalidone in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Northwind Health Company, LLC.

What Chlorthalidone is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

THALITONE is a thiazide-like diuretic indicated: • For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • as adjunctive therapy in edema associated with heart failure, cirrhosis of the liver, and renal disease, including nephrotic syndrome. …

— FDA label: Thalitone, Casper Pharma LLC, effective June 25, 2026. Read the full label on DailyMed →

The FDA has 77 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Heart failureHigh blood pressureStroke

Related medical specialties

CardiologyNeurology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 77 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet
RouteOral
Prescription products105 in the FDA NDC Directory
Brand namesThalitone, Hemiclor

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Chlorthalidone, by strength and form
Strength and formGeneric or brandPharmacies pay
chlorthalidone 12.5 mg
tablet		 Brand: Hemiclor $0.9571 per tablet
chlorthalidone 15 mg
tablet		 Brand: Thalitone $3.54 per tablet
chlorthalidone 25 mg
tablet		 Generic $0.0731 per tablet
chlorthalidone 50 mg
tablet		 Generic $0.1175 per tablet

NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA019574
THALITONE		 Casper Pharma LLCDecember 20, 1988 13, latest September 17, 2019
2019: Labeling · 2018: Labeling · 2004: Labeling
NDA218647
HEMICLOR		 Prm PharmaMarch 17, 2025 —

Generic approvals (18)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. September 3, 2026 · Class II · Ongoing · D-0852-2026

    Failed Dissolution Specifications

    Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01 — Inventia Healthcare Limited

  2. June 5, 2026 · Class II · Ongoing · D-0610-2026

    Failed Dissolution Specifications

    Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma — Inventia Healthcare Limited

  3. May 9, 2025 · Class II · Ongoing · D-0461-2025

    Failed Dissolution Specifications

    Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15 — AvKARE

  4. February 7, 2022 · Class II · Terminated · D-0578-2022

    Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

    Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-6 — SUN PHARMACEUTICAL INDUSTRIES INC

  5. January 26, 2022 · Class II · Terminated · D-0172-2024

    CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10 — CARDINAL HEALTHCARE

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)197498, 197499, 197500, 214081, 214083, 428539, 2709679
SPL set ID of the quoted labelbc5a0299-115b-4e60-bb3f-c75a95c51c15
FDA labels (SPL)77
FDA applicationsNDA019574, NDA218647, 18 ANDA
Active ingredients (FDA)CHLORTHALIDONE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Thalitone, Casper Pharma LLC, effective June 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers