Quick answers
- What is Chlorothiazide used for?
- The FDA-approved label (Diuril, Salix Pharmaceuticals, Inc, November 1, 2021) says: “DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. DIURIL has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Chlorothiazide have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Chlorothiazide?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated February 10, 2026). Ask your pharmacist about alternatives.
- Has Chlorothiazide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Chlorothiazide?
- 6 companies list prescription products of Chlorothiazide in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Sagent Pharmaceuticals and American Regent, Inc..
What Chlorothiazide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. DIURIL has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. …
— FDA label: Diuril, Salix Pharmaceuticals, Inc, effective November 1, 2021. Read the full label on DailyMed →
The FDA has 9 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.
Related medical specialties
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 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Suspension |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Diuril |
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.
- Fresenius Kabi USA, LLC3 products
- Sagent Pharmaceuticals2 products
- American Regent, Inc.1 product
- Gland Pharma Limited1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Salix Pharmaceuticals, Inc.1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA011870 DIURIL | Salix Pharms | October 6, 1961 | 24, latest June 10, 2009 2009: Labeling · 2009: Manufacturing (CMC) · 2007: Labeling |
Generic approvals (5)
- ANDA090896Fresenius Kabi USA · October 16, 2009
- ANDA091546Sun Pharm · July 26, 2011
- ANDA202561Am Regent · April 22, 2013
- ANDA202462Sagent Pharms Inc · May 29, 2015
- ANDA218630Gland · October 3, 2024
Shortage status
To be discontinued · updated February 10, 2026 · first posted February 10, 2026
| Product | Diuril, Oral Suspension, 250 mg/5mL (NDC 65649-311-12) |
|---|---|
| Company | Salix Pharmaceuticals, a division of Bausch Health US, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 213439, 309198, 484152 |
|---|---|
| SPL set ID of the quoted label | bd936e35-1af8-42da-bcc0-f22489d68574 |
| FDA labels (SPL) | 9 |
| FDA applications | NDA011870, 5 ANDA |
| Active ingredients (FDA) | CHLOROTHIAZIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Diuril, Salix Pharmaceuticals, Inc, effective November 1, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →