Prescription medicine
Chlorothiazide Brand names: Diuril
Chlorothiazide (Diuril) is a prescription medicine with an FDA approval on record since 1958. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the chlorothiazide FDA label on DailyMed (effective August 4, 2026, Sagent Pharmaceuticals); the NDA 11145 record on Drugs@FDA; every chlorothiazide label on DailyMed.
Highlights of the record
FDA label of August 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageChlorothiazide Sodium for Injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Forms and strengths
- 250 mg/5ml
- 500 mg/18ml
Injection (powder) (lyophilized) for solution; suspension.
On the market
- Earliest approval on file
- September 4, 1958 Diuril, Rising; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first July 17, 1975; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 0 since 2019 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 1,282 through July 30, 2026
What is chlorothiazide used for?
From the label: indications and usageChlorothiazide Sodium for Injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide Sodium for Injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Use in Pregnancy Routine use of diuretics during normal pregnancy 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 toxemia. […]
Conditions named in the indications of chlorothiazide's FDA labels, with every medicine labeled for each:
From other chlorothiazide labelsHeart failure: INDICATIONS AND USAGE Chlorothiazide Sodium for Injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Edema (fluid retention): Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy ).
High blood pressure: DIURIL is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
FDA pharmacologic class: Thiazide Diuretic.
Source: FDA drug label (chlorothiazide sodium), Sagent Pharmaceuticals, effective August 4, 2026 (SPL set 82dd0bdd-e6bd-48ea-8f58-c8bf71bbfe2c), via openFDA; the full label on DailyMed
Is there a generic for chlorothiazide (Diuril)?
The FDA approved the first generic chlorothiazide on July 17, 1975. 13 generic applications are approved; 5 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 chlorothiazide from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1958 earliest approval on file
- 1975 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is chlorothiazide in shortage?
No chlorothiazide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated February 10, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Diuril, Oral Suspension, 250 mg/5mL (NDC 65649-311-12) | Salix Pharmaceuticals, a division of Bausch Health US, LLC | To Be Discontinued | February 10, 2026 |
Every chlorothiazide presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has chlorothiazide been recalled?
The FDA's Enforcement Report lists 1 recall naming chlorothiazide since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of chlorothiazide and that holds 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.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 12, 2019 | Class II | CMC Enterprise Pharmacy not a listed maker | Lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the chlorothiazide label say about other medicines?
The chlorothiazide label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name chlorothiazide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | Cholestyramine and Colestipol Resins - Both cholestyramine and colestipol resins have the potential of binding thiazide diuretics and reducing diuretic absorption from the gastrointestinal tract. |
| Colestipol | drug interactions | Cholestyramine and Colestipol Resins - Both cholestyramine and colestipol resins have the potential of binding thiazide diuretics and reducing diuretic absorption from the gastrointestinal tract. |
| Lithium | drug interactions | Lithium - generally should not be given with diuretics. |
Source: FDA drug label (chlorothiazide sodium), Sagent Pharmaceuticals, effective August 4, 2026 (SPL set 82dd0bdd-e6bd-48ea-8f58-c8bf71bbfe2c), via openFDA; the full label on DailyMed
What do FAERS reports show for chlorothiazide?
The FDA Adverse Event Reporting System holds 1,282 reports that list chlorothiazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 201 are coded as a death and 647 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as chlorothiazide?
4 other medicines are given the same way (intravenous) and in the same FDA class as chlorothiazide or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Milrinone | Heart failure | 13 labelers | n/a | No current entry |
| Furosemide | Heart failure, Edema (fluid retention) | 13 labelers | $0.490 per mL 20 mg/2 mL vial | In shortage |
| Sodium nitroprusside | Heart failure | 12 labelers | n/a | No current entry |
| Ethacrynic acid | Heart failure, Edema (fluid retention) | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as chlorothiazide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to chlorothiazide
- 4 medicines for the same use
- Other thiazide diuretics
- the pharmacologic class, with prices and generics
- Chlorothiazide side effects
- the label's list beside FAERS reports
- Chlorothiazide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other