Prescription medicine
Fosinopril and hydrochlorothiazide First approved as Monopril-Hct
Fosinopril and hydrochlorothiazide (Monopril-Hct) is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $0.634 per fosinopril-hydrochlorothiazide 10-12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fosinopril and hydrochlorothiazide FDA label on DailyMed (effective April 28, 2024, Aurobindo Pharma Limited); the NDA 20286 record on Drugs@FDA; every fosinopril and hydrochlorothiazide label on DailyMed.
Highlights of the record
FDA label of April 28, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue fosinopril and hydrochlorothiazide 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 usageFosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
Forms and strengths
- 10 mg / 12.5 mg
- 20 mg / 12.5 mg
Tablet.
On the market
- Earliest approval on file
- November 30, 1994 Monopril-Hct, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first December 3, 2004; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.634 per tablet Fosinopril-hydrochlorothiazide 10-12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest October 11, 2013
- FAERS reports
- 63 through July 30, 2026
What is fosinopril and hydrochlorothiazide used for?
From the label: indications and usageFosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION . ) In using fosinopril sodium and hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ). […]
Conditions named in the indications of fosinopril and hydrochlorothiazide's FDA labels, with every medicine labeled for each:
From other fosinopril and hydrochlorothiazide labelsHigh blood pressure: INDICATIONS AND USAGE Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor and Thiazide Diuretic.
Source: FDA drug label (Fosinopril Sodium and Hydrochlorothiazide), Aurobindo Pharma Limited, effective April 28, 2024 (SPL set 35019655-9a30-4305-a262-936ad0e73071), via openFDA; the full label on DailyMed
Is there a generic for fosinopril and hydrochlorothiazide (Monopril-Hct)?
The FDA approved the first generic fosinopril and hydrochlorothiazide on December 3, 2004. 9 generic applications are approved; 3 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 fosinopril and hydrochlorothiazide from 2 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.
- 1994 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fosinopril and hydrochlorothiazide (Monopril-Hct)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.634 per Fosinopril-hydrochlorothiazide 10-12.5 mg tablet, up 34% from $0.474 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Fosinopril-hydrochlorothiazide 20-12.5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fosinopril-hydrochlorothiazide 10-12.5 mg tablet | Generic | $0.634 per tablet | $19.03 | +34% |
| Fosinopril-hydrochlorothiazide 20-12.5 mg tablet | Generic | $0.560 per tablet | $16.79 | -9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fosinopril and hydrochlorothiazide been recalled?
The FDA's Enforcement Report lists 1 recall naming fosinopril and hydrochlorothiazide since 2013: 0 Class I (the most serious), 1 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 11, 2013 | Class II | Sandoz Inc | Subpotent; Hydrochlorothiazide at the 9 month time point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fosinopril and hydrochlorothiazide label say about other medicines?
The fosinopril and hydrochlorothiazide label names 19 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 | drug interactions | Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. |
| Amiloride | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. |
| Aspirin | drug interactions | Other The bioavailability of unbound fosinoprilat is not altered by coadministration of fosinopril with aspirin, chlorthalidone, cimetidine, digoxin, metoclopramide, nifedipine, propranolol, propantheline, or warfarin. |
| Captopril | warnings | Neutropenia/Agranulocytosis Another angiotensin-converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients (incidence probably less than once per 10,000 exposures), but more frequently (incidence possibly as great as once per 1,000 … |
| Chlorthalidone | drug interactions | Other The bioavailability of unbound fosinoprilat is not altered by coadministration of fosinopril with aspirin, chlorthalidone, cimetidine, digoxin, metoclopramide, nifedipine, propranolol, propantheline, or warfarin. |
| Cholestyramine | drug interactions | Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. |
| Cimetidine | drug interactions | Other The bioavailability of unbound fosinoprilat is not altered by coadministration of fosinopril with aspirin, chlorthalidone, cimetidine, digoxin, metoclopramide, nifedipine, propranolol, propantheline, or warfarin. |
| Colestipol | drug interactions | Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. |
| Digoxin | drug interactions | Other The bioavailability of unbound fosinoprilat is not altered by coadministration of fosinopril with aspirin, chlorthalidone, cimetidine, digoxin, metoclopramide, nifedipine, propranolol, propantheline, or warfarin. |
| Epinephrine | warnings | When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine injection 1:1000 (0.3 to 0.5 mL) should be promptly administered (see PRECAUTIONS and ADVERSE REACTIONS ). |
| Lithium | drug interactions | Lithium Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. |
| Magnesium hydroxide | drug interactions | Antacids In a clinical pharmacology study, serum levels and urinary excretion of fosinoprilat were reduced when fosinopril was coadministered with an antacid (aluminum hydroxide, magnesium hydroxide, and simethicone) suggesting that antacids may impair absorption of fosinopril. |
| Methenamine | drug interactions | By alkalinizing the urine, hydrochlorothiazide may decrease the effectiveness of methenamine. |
| Metoclopramide | drug interactions | Other The bioavailability of unbound fosinoprilat is not altered by coadministration of fosinopril with aspirin, chlorthalidone, cimetidine, digoxin, metoclopramide, nifedipine, propranolol, propantheline, or warfarin. |
Every other medicine the fosinopril and hydrochlorothiazide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nifedipine | drug interactions | … with aspirin, chlorthalidone, cimetidine, digoxin, metoclopramide, nifedipine, propranolol, propantheline, or warfarin. |
| Propranolol | drug interactions | … aspirin, chlorthalidone, cimetidine, digoxin, metoclopramide, nifedipine, propranolol, propantheline, or warfarin. |
| Spironolactone | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. |
| Triamterene | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. |
| Warfarin | drug interactions | Interaction studies with warfarin have failed to identify any clinically important effects of fosinopril on the serum concentration or clinical effects of the anticoagulant. |
Check fosinopril and hydrochlorothiazide against other medicines
Source: FDA drug label (Fosinopril Sodium and Hydrochlorothiazide), Aurobindo Pharma Limited, effective April 28, 2024 (SPL set 35019655-9a30-4305-a262-936ad0e73071), via openFDA; the full label on DailyMed
What do FAERS reports show for fosinopril and hydrochlorothiazide?
The FDA Adverse Event Reporting System holds 63 reports that list fosinopril and hydrochlorothiazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 40 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 fosinopril and hydrochlorothiazide?
56 other medicines are given the same way (oral) and in the same FDA class as fosinopril and hydrochlorothiazide 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 |
| Quinapril | High blood pressure | 9 labelers | n/a | In shortage |
| Trandolapril | High blood pressure | 5 labelers | $0.157 per tablet 1 mg tablet | No current entry |
Every medicine labeled for the same conditions as fosinopril and hydrochlorothiazide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fosinopril and hydrochlorothiazide
- 56 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Fosinopril and hydrochlorothiazide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other