Prescription medicine
Amiloride and hydrochlorothiazide First approved as Moduretic 5-50
Amiloride and hydrochlorothiazide (Moduretic 5-50) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $0.450 per amiloride HCl-hydrochlorothiazide 5-50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amiloride and hydrochlorothiazide FDA label on DailyMed (effective December 27, 2022, Teva Pharmaceuticals USA, Inc.); the NDA 18201 record on Drugs@FDA; every amiloride and hydrochlorothiazide label on DailyMed.
Highlights of the record
FDA label of December 27, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Like other potassium-conserving diuretic combinations, amiloride and hydrochlorothiazide may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter). In patients without renal impairment or diabetes mellitus, the risk of hyperkalemia with this combination product is about 1 to 2 percent. This risk is higher in patients with renal impairment or diabetes mellitus (even without recognized diabetic nephropathy). Since hyperkalemia, if uncorrected, is potentially fatal, it is essential to monitor serum potassium levels carefully in any patient receiving amiloride hydrochloride and hydrochlorothiazide, particularly when it is first introduced, at the time of dosage adjustments, and during any illness that could affect renal function.
Used for
From the label: indications and usageAmiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias.
Forms and strengths
- 5 mg / 50 mg
Tablet.
On the market
- Earliest approval on file
- October 5, 1981 Moduretic 5-50, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first August 6, 1986; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.450 per tablet Amiloride HCl-hydrochlorothiazide 5-50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 64 through July 30, 2026
What is amiloride and hydrochlorothiazide used for?
From the label: indications and usageAmiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. […]
Conditions named in the indications of amiloride and hydrochlorothiazide's FDA labels, with every medicine labeled for each:
From other amiloride and hydrochlorothiazide labelsHeart failure: INDICATIONS AND USAGE Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used …
FDA pharmacologic class: Potassium-sparing Diuretic and Thiazide Diuretic.
Source: FDA drug label (Amiloride Hydrochloride and Hydrochlorothiazide), ANDA071111 (Barr), as published by Teva Pharmaceuticals USA, Inc., effective December 27, 2022 (SPL set 8b2c581a-f955-4a8e-bf85-e768e903fd10), via openFDA; the full label on DailyMed
Is there a generic for amiloride and hydrochlorothiazide (Moduretic 5-50)?
The FDA approved the first generic amiloride and hydrochlorothiazide on August 6, 1986. 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 amiloride and hydrochlorothiazide from 1 labeler 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.
- 1981 earliest approval on file
- 1986 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amiloride and hydrochlorothiazide (Moduretic 5-50)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.450 per Amiloride HCl-hydrochlorothiazide 5-50 mg tablet, about the same as a year earlier. 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.
- Amiloride HCl-hydrochlorothiazide 5-50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amiloride HCl-hydrochlorothiazide 5-50 mg tablet | Generic | $0.450 per tablet | $13.50 | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the amiloride and hydrochlorothiazide label say about other medicines?
The amiloride and hydrochlorothiazide label names 10 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 |
|---|---|---|
| Cholestyramine | drug interactions | Single doses of cholestyramine and colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia. |
| Colestipol | drug interactions | Single doses of cholestyramine and colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia. |
| Cyclosporine | drug interactions | Amiloride HCl When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. |
| Indomethacin | drug interactions | Since indomethacin and potassium-sparing diuretics, including this product, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently. |
| Lithium | drug interactions | Lithium Generally should not be given with diuretics. |
| Sodium bicarbonate | warnings | Such measures include the intravenous administration of sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation. |
| Sodium polystyrene sulfonate | warnings | If needed, a cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema. |
| Spironolactone | contraindications | Antikaliuretic Therapy or Potassium Supplementation Amiloride hydrochloride and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. |
| Tacrolimus | drug interactions | Amiloride HCl When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. |
| Triamterene | contraindications | Antikaliuretic Therapy or Potassium Supplementation Amiloride hydrochloride and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. |
Check amiloride and hydrochlorothiazide against other medicines
Source: FDA drug label (Amiloride Hydrochloride and Hydrochlorothiazide), ANDA071111 (Barr), as published by Teva Pharmaceuticals USA, Inc., effective December 27, 2022 (SPL set 8b2c581a-f955-4a8e-bf85-e768e903fd10), via openFDA; the full label on DailyMed
What do FAERS reports show for amiloride and hydrochlorothiazide?
The FDA Adverse Event Reporting System holds 64 reports that list amiloride and hydrochlorothiazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 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 amiloride and hydrochlorothiazide?
14 other medicines are given the same way (oral) and in the same FDA class as amiloride and 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 |
|---|---|---|---|---|
| Triamterene | Heart failure | 3 labelers | $5.98 per capsule 50 mg capsule | No current entry |
| Chlorothiazide | Heart failure | none listed | n/a | A presentation being discontinued |
| Carvedilol | Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Spironolactone | Heart failure | 38 labelers | $0.0426 per tablet 25 mg tablet | A presentation being discontinued |
| Furosemide | Heart failure | 33 labelers | $0.026 per tablet 20 mg tablet | In shortage |
| Sacubitril and valsartan | Heart failure | 27 labelers | $0.533 per unit 49-51 mg | No current entry |
| Bumetanide | Heart failure | 24 labelers | $0.108 per tablet 1 mg tablet | Resolved |
| Digoxin | Heart failure | 21 labelers | $0.133 per tablet 125 mcg tablet | No current entry |
Every medicine labeled for the same conditions as amiloride and hydrochlorothiazide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amiloride and hydrochlorothiazide
- 14 medicines for the same use
- Other potassium-sparing diuretics
- the pharmacologic class, with prices and generics
- Amiloride and hydrochlorothiazide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other