Prescription medicine

Captopril and hydrochlorothiazide First approved as Capozide 50/25

Captopril and hydrochlorothiazide (Capozide 50/25) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed
Boxed warning

Check it at the source: the captopril and hydrochlorothiazide FDA label on DailyMed (effective February 21, 2023, Rising Pharma Holdings, Inc.); the NDA 18709 record on Drugs@FDA; every captopril and hydrochlorothiazide label on DailyMed.

Highlights of the record

FDA label of February 21, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

USE IN PREGNANCY.

When used in pregnancy during the second and third trimesters, ACE Inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, captopril and hydrochlorothiazide should be discontinued as soon as possible. See WARNINGS: Captopril: Fetal/Neonatal Morbidity and Mortality.

Used for

From the label: indications and usage
Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension.

Forms and strengths

25 mg / 15 mg
25 mg / 25 mg
50 mg / 15 mg
50 mg / 25 mg

Tablet.

On the market

Earliest approval on file: October 12, 1984 Capozide 50/25, Apothecon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 5 first December 29, 1997; 1 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): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 73 through July 30, 2026

What is captopril and hydrochlorothiazide used for?

From the label: indications and usage
Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate. […]

Conditions named in the indications of captopril and hydrochlorothiazide's FDA labels, with every medicine labeled for each:

High blood pressure

From other captopril and hydrochlorothiazide labels
High blood pressure: INDICATIONS & USAGE Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension.

FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor and Thiazide Diuretic.

Source: FDA drug label (CAPTOPRIL AND HYDROCHLOROTHIAZIDE), Rising Pharma Holdings, Inc., effective February 21, 2023 (SPL set 0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e), via openFDA; the full label on DailyMed

Is there a generic for captopril and hydrochlorothiazide (Capozide 50/25)?

The FDA approved the first generic captopril and hydrochlorothiazide on December 29, 1997. 5 generic applications are approved; 1 of them carries 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 captopril 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.

1984 earliest approval on file
1997 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the captopril and hydrochlorothiazide label say about other medicines?

The captopril and hydrochlorothiazide label names 17 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
Allopurinol	warnings	In foreign marketing experience in patients with renal failure, use of allopurinol concomitantly with captopril has been associated with neutropenia but this association has not appeared in U.S. reports.
Amiloride	drug interactions	Potassium-sparing diuretics such as spironolactone, triamterene, or amiloride, or potassium supplements, should be given only for documented hypokalemia, and then with caution, since they may lead to a significant increase of serum potassium.
Amphotericin b	drug interactions	Amphotericin B, Corticosteroids, or Corticotropin (ACTH): may intensify electrolyte imbalance, particularly hypokalemia.
Aspirin	drug interactions	Other non-steroidal anti-inflammatory agents (e.g., aspirin) may also have this effect.
Cholestyramine	drug interactions	Monitor potassium levels (see PRECAUTIONS: Drug Interactions: Cholestyramine and Colestipol Resins:
Colestipol	drug interactions	Monitor potassium levels (see PRECAUTIONS: Drug Interactions: Cholestyramine and Colestipol Resins:
Corticotropin	drug interactions	Amphotericin B, Corticosteroids, or Corticotropin (ACTH): may intensify electrolyte imbalance, particularly hypokalemia.
Diazoxide	drug interactions	Diazoxide: enhanced hyperglycemic, hyperuricemic, and antihypertensive effects.
Epinephrine	warnings	Emergency therapy, including but not necessarily limited to, subcutaneous administration of a 1:1000 solution of epinephrine should be promptly instituted.
Indomethacin	drug interactions	Inhibitors of Endogenous Prostaglandin Synthesis: It has been reported that indomethacin may reduce the antihypertensive effect of captopril, especially in cases of low renin hypertension.
Lithium	drug interactions	Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy.
Methenamine	drug interactions	Methenamine: possible decreased effectiveness due to alkalinization of the urine.
Nitroglycerin	drug interactions	Agents Having Vasodilator Activity: Data on the effect of concomitant use of other vasodilators in patients receiving captopril for heart failure are not available; therefore, nitroglycerin or other nitrates (as used for management of angina) or other drugs having vasodilator activity should, if possible, be …
Probenecid	drug interactions	Probenecid or Sulfinpyrazone: increased dosage of these agents may be necessary since hydrochlorothiazide may have hyperuricemic effects.

Every other medicine the captopril and hydrochlorothiazide label names

Medicine named	Section	What the label says
Procainamide	warnings	About half of the reported cases had serum creatinine ≥ 1.6 mg/dL and more than 75 percent were in patients also receiving procainamide.
Spironolactone	drug interactions	Potassium-sparing diuretics such as spironolactone, triamterene, or amiloride, or potassium supplements, should be given only for documented hypokalemia, and then with caution, since they may lead to …
Triamterene	drug interactions	Potassium-sparing diuretics such as spironolactone, triamterene, or amiloride, or potassium supplements, should be given only for documented hypokalemia, and then with caution, since they may lead to …

Check captopril and hydrochlorothiazide against other medicines

What do FAERS reports show for captopril and hydrochlorothiazide?

The FDA Adverse Event Reporting System holds 73 reports that list captopril and hydrochlorothiazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 52 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

Drug Interaction (a use or a product term, not a reaction)8
Hyponatraemia (named in the label)8
Diarrhoea (named in the label)7
Hypotension (named in the label)6
Renal Failure Acute6
Abdominal Pain (named in the label)5
Asthenia (named in the label)5
Confusional State5

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as captopril and hydrochlorothiazide?

56 other medicines are given the same way (oral) and in the same FDA class as captopril 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
Quinapril	High blood pressure	9 labelers	n/a	In shortage
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 captopril and hydrochlorothiazide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to captopril and hydrochlorothiazide: 56 medicines for the same use
Other ACE inhibitors: the pharmacologic class, with prices and generics
Captopril and hydrochlorothiazide side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other