Prescription medicine
Hydrochlorothiazide and quinapril First approved as Accuretic
Hydrochlorothiazide and quinapril (Accuretic) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the hydrochlorothiazide and quinapril FDA label on DailyMed (effective December 11, 2023, Chartwell RX, LLC); the NDA 20125 record on Drugs@FDA; every hydrochlorothiazide and quinapril label on DailyMed.
Highlights of the record
FDA label of December 11, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue quinapril and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity
Used for
From the label: indications and usageHypertension Quinapril and hydrochlorothiazide tablets is indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 10 mg / 12.5 mg
- 20 mg / 12.5 mg
- 20 mg / 25 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- December 28, 1999 Accuretic, Pfizer Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first March 31, 2004; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 3 of 6 presentations limited or unavailable updated October 2, 2026
- Recalls by its makers (FDA)
- 4 since 2022 0 Class I among all firms' recalls; latest October 5, 2022
- FAERS reports
- 115 through July 30, 2026
What is hydrochlorothiazide and quinapril used for?
From the label: indications and usageHypertension Quinapril and hydrochlorothiazide tablets is 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril and hydrochlorothiazide tablets. […]
Conditions named in the indications of hydrochlorothiazide and quinapril's FDA labels, with every medicine labeled for each:
From other hydrochlorothiazide and quinapril labelsHigh blood pressure: INDICATIONS AND USAGE Hypertension Quinapril and hydrochlorothiazide tablets is indicated for the treatment of hypertension, to lower blood pressure.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor and Thiazide Diuretic.
Source: FDA drug label (Quinapril and Hydrochlorothiazide), Chartwell RX, LLC, effective December 11, 2023 (SPL set 2eae533f-d0af-47e8-a1f2-94bc8cc89b5a), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide and quinapril (Accuretic)?
The FDA approved the first generic hydrochlorothiazide and quinapril on March 31, 2004. 6 generic applications are approved; 2 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 and quinapril from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2004 first generic approved
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is hydrochlorothiazide and quinapril in shortage?
The FDA Drug Shortage Database lists 3 of 6 hydrochlorothiazide and quinapril presentations as limited or unavailable (updated October 2, 2026); the first entry was posted on January 19, 2023. 3 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Quinapril Hydrochloride And Hydrochlorothiazide, Tablet, 12.5 mg; 10 mg (NDC 65862-161-90) | Aurobindo Pharma USA | Current | October 2, 2026 |
| Quinapril Hydrochloride And Hydrochlorothiazide, Tablet, 12.5 mg; 20 mg (NDC 65862-162-90) | Aurobindo Pharma USA | Current | October 2, 2026 |
| Quinapril Hydrochloride And Hydrochlorothiazide, Tablet, 25 mg; 20 mg (NDC 65862-163-90) | Aurobindo Pharma USA | Current | October 2, 2026 |
| Quinapril/Hydrochlorothiazide, Tablet, 12.5 mg; 10 mg (NDC 62135-667-90) | Chartwell Molecular Holdings LLC | Current | October 2, 2026 |
| Quinapril/Hydrochlorothiazide, Tablet, 12.5 mg; 20 mg (NDC 62135-668-90) | Chartwell Molecular Holdings LLC | Current | October 2, 2026 |
| Quinapril/Hydrochlorothiazide, Tablet, 25 mg; 20 mg (NDC 62135-669-90) | Chartwell Molecular Holdings LLC | Current | October 2, 2026 |
Every hydrochlorothiazide and quinapril presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has hydrochlorothiazide and quinapril been recalled?
The FDA's Enforcement Report lists 4 recalls naming hydrochlorothiazide and quinapril since 2022: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 5, 2022 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. |
| March 21, 2022 | Class II | Pfizer Inc. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrochlorothiazide and quinapril label say about other medicines?
The hydrochlorothiazide and quinapril label names 5 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer quinapril and hydrochlorothiazide tablets with aliskiren: in patients with diabetes. |
| Captopril | warnings | Neutropenia/Agranulocytosis: Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen vascular disease, such as systemic lupus … |
| Epinephrine | warnings | Where there is involvement of the tongue, glottis, or larynx likely to cause airway obstruction, emergency therapy including, but not limited to, subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL) should be promptly administered (see PRECAUTIONS and ADVERSE REACTIONS ). |
| Sacubitril and valsartan | contraindications | Do not administer quinapril and hydrochlorothiazide tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS ). |
| Temsirolimus | warnings | Patients taking concomitant mammalian target of rapamycin (mTOR inhibitor) (e.g., temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema. |
Check hydrochlorothiazide and quinapril against other medicines
Source: FDA drug label (Quinapril and Hydrochlorothiazide), Chartwell RX, LLC, effective December 11, 2023 (SPL set 2eae533f-d0af-47e8-a1f2-94bc8cc89b5a), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide and quinapril?
The FDA Adverse Event Reporting System holds 115 reports that list hydrochlorothiazide and quinapril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 25 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.
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 and quinapril?
56 other medicines are given the same way (oral) and in the same FDA class as hydrochlorothiazide and quinapril 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.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lisinopril | High blood pressure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Enalapril | High blood pressure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Benazepril | High blood pressure | 21 labelers | $0.0789 per tablet 20 mg tablet | No current entry |
| Ramipril | High blood pressure | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Captopril | High blood pressure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Fosinopril | High blood pressure | 7 labelers | $0.154 per tablet 10 mg tablet | No current entry |
| Trandolapril | High blood pressure | 5 labelers | $0.157 per tablet 1 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydrochlorothiazide and quinapril
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydrochlorothiazide and quinapril
- 56 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide and quinapril side effects
- the label's list beside FAERS reports
- Hydrochlorothiazide and quinapril shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other