Prescription medicine
Hydrochlorothiazide Brand names: Inzirqo; first approved as Esidrix
Hydrochlorothiazide (Inzirqo) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.0115 per hydrochlorothiazide 25 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $4.46 per mL (Inzirqo 10 mg/mL oral suspension).
- Generic listed
- A presentation discontinued
Check it at the source: the hydrochlorothiazide FDA label on DailyMed (effective June 12, 2026, Leading Pharma, LLC); the NDA 11793 record on Drugs@FDA; every hydrochlorothiazide label on DailyMed.
Highlights of the record
FDA label of June 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageHydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Forms and strengths
- 12.5 mg
- 25 mg
- 50 mg
- 10 mg/ml
Tablet; capsule; gelatin-coated capsule; powder for suspension.
On the market
- Earliest approval on file
- February 12, 1959 Esidrix, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 75 first January 12, 1973; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 44 of which 43 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 23, 2044 Inzirqo for oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0115 per tablet Hydrochlorothiazide 25 mg tablet
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 7 since 2013 1 Class I among all firms' recalls; latest July 27, 2020; 2 more by firms not listed as its makers
- FAERS reports
- 144,413 through July 30, 2026
What is hydrochlorothiazide used for?
From the label: indications and usageHydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are 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. […]
Conditions named in the indications of hydrochlorothiazide's FDA labels, with every medicine labeled for each:
From other hydrochlorothiazide labelsHeart failure: INDICATIONS AND USAGE Hydrochlorothiazide tablets USP are 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 ).
FDA pharmacologic class: Thiazide Diuretic.
Source: FDA drug label (HYDROCHLOROTHIAZIDE), Leading Pharma, LLC, effective June 12, 2026 (SPL set 8c868894-667e-4a51-906a-838d63e420ba), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide (Inzirqo)?
The FDA approved the first generic hydrochlorothiazide on January 12, 1973. 75 generic applications are approved; 15 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 hydrochlorothiazide from 43 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.
The Orange Book lists 1 patent for Inzirqo for oral suspension, the last expiring on January 23, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1959 earliest approval on file
- 1973 first generic approved
- 2044 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 hydrochlorothiazide (Inzirqo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0115 per Hydrochlorothiazide 25 mg tablet, down 7% from $0.0124 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.
- Hydrochlorothiazide 25 mg tablet (generic)
- Inzirqo 10 mg/mL oral suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydrochlorothiazide 12.5 mg capsule | Generic | $0.0275 per capsule | $0.826 | -9% |
| Hydrochlorothiazide 12.5 mg tablet | Generic | $0.034 per tablet | $1.02 | -20% |
| Hydrochlorothiazide 25 mg tablet | Generic | $0.0115 per tablet | $0.346 | -7% |
| Hydrochlorothiazide 50 mg tablet | Generic | $0.0316 per tablet | $0.949 | -6% |
| Inzirqo 10 mg/mL oral suspension | Brand | $4.46 per mL | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is hydrochlorothiazide in shortage?
No hydrochlorothiazide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated November 19, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Microzide, Capsule, 12.5 mg (NDC 0591-0347-01) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | November 19, 2025 |
| Microzide, Capsule, 12.5 mg (NDC 0591-0347-05) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | November 19, 2025 |
Every hydrochlorothiazide presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has hydrochlorothiazide been recalled?
The FDA's Enforcement Report lists 9 recalls naming hydrochlorothiazide since 2013: 1 Class I (the most serious), 8 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of hydrochlorothiazide 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.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 27, 2020 | Class II | Calvin Scott & Company, Inc. | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. |
| August 21, 2018 | Class I | Accord Healthcare, Inc. | Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg. |
| October 29, 2015 | Class II | Amerisource Health Services | Presence of Particulate Matter |
| October 7, 2015 | Class II | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Presence of Particulate Matter. |
| July 30, 2015 | Class II | Unichem Pharmaceuticals Usa Inc | Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; HYDROCHLOROTHIAZIDE Tablet, 12.5 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg may have potentially been mislabeled as one of the following drugs: hydrALAZINE HCl, Tablet, 100 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrochlorothiazide label say about other medicines?
The hydrochlorothiazide label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name hydrochlorothiazide. 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 - Cholestyramine and colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. |
| Colestipol | drug interactions | Cholestyramine and colestipol resins - Cholestyramine and colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. |
| Lithium | warnings | Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions ). |
Other labels that name hydrochlorothiazide
Source: FDA drug label (HYDROCHLOROTHIAZIDE), Leading Pharma, LLC, effective June 12, 2026 (SPL set 8c868894-667e-4a51-906a-838d63e420ba), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide?
The FDA Adverse Event Reporting System holds 144,413 reports that list hydrochlorothiazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,118 are coded as a death and 49,740 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 hydrochlorothiazide?
28 other medicines are given the same way (oral) and in the same FDA class as hydrochlorothiazide 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. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Chlorothiazide | High blood pressure, Heart failure, Edema (fluid retention) | none listed | n/a | A presentation being discontinued |
| Metoprolol | High blood pressure, Heart failure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Lisinopril | High blood pressure, Heart failure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Carvedilol | High blood pressure, Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Spironolactone | High blood pressure, Heart failure, Edema (fluid retention) | 38 labelers | $0.0426 per tablet 25 mg tablet | A presentation being discontinued |
| Valsartan | High blood pressure, Heart failure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Furosemide | High blood pressure, Heart failure | 33 labelers | $0.026 per tablet 20 mg tablet | In shortage |
| Enalapril | High blood pressure, Heart failure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydrochlorothiazide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does hydrochlorothiazide compare with medicines for the same use?
17 side-by-side pages set hydrochlorothiazide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to hydrochlorothiazide
- 28 medicines for the same use
- Other thiazide diuretics
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide side effects
- the label's list beside FAERS reports
- Hydrochlorothiazide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other