Hydrochlorothiazide
Tablet · Oral
Uses
Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
Dosage and administration
For Control of Hypertension: The adult initial dose of hydrochlorothiazide is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.
Contraindications
Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
Warnings
Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Diabetes and Hypoglycemia: Latent diabetes mellitus may become manifest and diabetic patients given thiazides may require adjustment of their insulin dose. Renal Disease: Cumulative effects of the thiazides may develop in patients with impaired renal function. In such patients, thiazides may precipitate azotemia.
Precautions
Electrolyte and Fluid Balance Status: In published studies, clinically significant hypokalemia has been consistently less common in patients who received 12.5 mg of hydrochlorothiazide than in patients who received higher doses. Nevertheless, periodic determination of serum electrolytes should be performed in patients who may be at risk for the development of hypokalemia. Patients should be observed for signs of fluid or electrolyte disturbances, i.e., hyponatremia, hypochloremic alkalosis, and hypokalemia and hypomagnesemia. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop, especially with brisk diuresis when severe cirrhosis is present, during concomitant use of corticosteroid or adrenocorticotropic hormone (ACTH) or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia and hypomagnesemia can provoke ventricular arrhythmias or sensitize or exaggerate the response of the heart to the toxic effects of digitalis. Hypokalemia may be avoided or treated by potassium supplementation or increased intake of potassium rich foods. Dilutional hyponatremia is life-threatening and may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than salt administration, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice. Hyperuricemia: Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics. Impaired Hepatic Function: Thiazides should be used with caution in patients with impaired hepatic function. They can precipitate hepatic coma in patients with severe liver disease. Parathyroid Disease: Calcium excretion is decreased by thiazides, and pathologic changes in the parathyroid glands, with hypercalcemia and hypophosphatemia, have been observed in a few patients on prolonged thiazide therapy. Information for Patients: Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. Drug Interactions: When given concurrently the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotics - potentiation of orthostatic hypotension may occur. Antidiabetic drugs - (oral agents and insulin) dosage adjustment of the antidiabetic drug may be required. Other antihypertensive drugs - additive effect or potentiation. 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. Corticosteroid, ACTH – intensified electrolyte depletion, particularly hypokalemia. Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant. Lithium - generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and greatly increase the risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide. Non-steroidal anti-inflammatory drugs - In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. When hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patients should be observed closely to determine if the desired effect of the diuretic is obtained. Drug/Laboratory Test Interactions - Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General ). Carcinogenesis, Mutagenesis, Impairment of Fertility: Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1,300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration. Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation. Pregnancy: Teratogenic Effects: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3,000 and 1,000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women.
Side effects
The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the order of decreasing severity. Body as a whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic: Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal: Muscle spasm. Nervous System/Psychiatric: Vertigo, paresthesia, dizziness, headache, restlessness. Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS ). Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses: Transient blurred vision, xanthopsia. Urogenital: Impotence. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn. Postmarketing Experience: The following adverse reaction has been identified during post-approval use of hydrochlorothiazide. Because the reaction is reported voluntarily from a population of uncertain size, it is not possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.
Drug interactions
Drug Interactions: When given concurrently the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotics - potentiation of orthostatic hypotension may occur. Antidiabetic drugs - (oral agents and insulin) dosage adjustment of the antidiabetic drug may be required. Other antihypertensive drugs - additive effect or potentiation. 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. Corticosteroid, ACTH – intensified electrolyte depletion, particularly hypokalemia. Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant. Lithium - generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and greatly increase the risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide. Non-steroidal anti-inflammatory drugs - In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. When hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patients should be observed closely to determine if the desired effect of the diuretic is obtained. Drug/Laboratory Test Interactions - Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General ). Carcinogenesis, Mutagenesis, Impairment of Fertility: Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1,300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration. Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.
Pregnancy
Pregnancy: Teratogenic Effects: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3,000 and 1,000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic Effects: Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults. Nursing Mothers: Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue hydrochlorothiazide, taking into account the importance of the drug to the mother.
Pediatric use
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Overdosage
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 gm/kg in the mouse and rat.
Description
Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 ; its molecular weight is 297.74; and its structural formula is: It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate. Gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, titanium dioxide. The capsules are printed with edible ink containing black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40. Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical
How supplied
Hydrochlorothiazide Capsules, USP are #4 Teal Opaque/White Opaque two piece hard gelatin capsules imprinted with WATSON 347 and 12.5 mg in black ink. They are supplied in bottles of 30 (NDC 42708-027-30) are supplied with child resistant closures. Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed. Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. 12/2023
Patient information
Information for Patients: Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
Label text from the FDA structured product label by QPharma, Inc. (revised Dec 5, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydrochlorothiazide in 167 products
Hydrochlorothiazide NDC products (167)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7764 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-1088 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5057 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5333 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6014 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6156 | Hydrochlorothiazide 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6157 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6158 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6160 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6372 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6532 | Hydrochlorothiazide 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6931 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6987 | Hydrochlorothiazide 12.5 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6988 | Hydrochlorothiazide 12.5 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7765 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7772 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7773 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7817 | Hydrochlorothiazide 12.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-0724 | Hydrochlorothiazide 12.5 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0141 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-0140 | Hydrochlorothiazide 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 16729-184 | Hydrochlorothiazide 50 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-183 | Hydrochlorothiazide 25 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-182 | Hydrochlorothiazide 12.5 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 0228-2820 | Hydrochlorothiazide 12.5 mg/1 Tablet | Actavis Pharma, Inc. | ANDA |
| 62332-070 | Hydrochlorothiazide 12.5 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-438 | Hydrochlorothiazide 12.5 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA |
| 60687-894 | Hydrochlorothiazide 25 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-683 | Hydrochlorothiazide 12.5 mg/1 Capsule | American Health Packaging | ANDA |
| 60687-593 | Hydrochlorothiazide 25 mg/1 Tablet | American Health Packaging | ANDA |
| 53401-038 | Hydrochlorothiazide 12.5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-697 | Hydrochlorothiazide 12.5 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-471 | Hydrochlorothiazide 50 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-488 | Hydrochlorothiazide 25 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-500 | Hydrochlorothiazide 12.5 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-240 | Hydrochlorothiazide 50 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-717 | Hydrochlorothiazide 50 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-719 | Hydrochlorothiazide 25 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 65862-133 | Hydrochlorothiazide 25 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-134 | Hydrochlorothiazide 50 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-113 | Hydrochlorothiazide 12.5 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 50268-404 | Hydrochlorothiazide 12.5 mg/1 Capsule | AvPAK | ANDA |
| 72162-1528 | Hydrochlorothiazide 12.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 72162-1357 | Hydrochlorothiazide 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-9647 | Hydrochlorothiazide 12.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-1218 | Hydrochlorothiazide 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-1220 | Hydrochlorothiazide 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-7782 | Hydrochlorothiazide 12.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8498 | Hydrochlorothiazide 12.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-8992 | Hydrochlorothiazide 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1976 | Hydrochlorothiazide 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1713 | Hydrochlorothiazide 12.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-1481 | Hydrochlorothiazide 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1451 | Hydrochlorothiazide 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0770 | Hydrochlorothiazide 12.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-0652 | Hydrochlorothiazide 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0269 | Hydrochlorothiazide 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0145 | Hydrochlorothiazide 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0067 | Hydrochlorothiazide 12.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 62135-738 | Hydrochlorothiazide 12.5 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-449 | Hydrochlorothiazide 50 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-448 | Hydrochlorothiazide 25 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 67046-1664 | Hydrochlorothiazide 12.5 mg/1 Tablet | Coupler LLC | ANDA |
| 72189-263 | Hydrochlorothiazide 50 mg/1 Tablet | DIRECT RX | ANDA |
| 72189-513 | Hydrochlorothiazide 50 mg/1 Tablet | Direct_Rx | ANDA |
| 76282-155 | Hydrochlorothiazide 50 mg/1 Tablet | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-154 | Hydrochlorothiazide 25 mg/1 Tablet | Exelan Pharmaceuticals Inc. | ANDA |
| 51407-331 | Hydrochlorothiazide 25 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-332 | Hydrochlorothiazide 50 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-330 | Hydrochlorothiazide 12.5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 23155-008 | Hydrochlorothiazide 25 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-009 | Hydrochlorothiazide 50 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-764 | Hydrochlorothiazide 12.5 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 55700-006 | Hydrochlorothiazide 25 mg/1 Tablet | Lake Erie Medical DBA Quality Care Products LLC | ANDA |
| 69315-155 | Hydrochlorothiazide 12.5 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 69315-131 | Hydrochlorothiazide 25 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 69315-130 | Hydrochlorothiazide 50 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 68645-510 | Hydrochlorothiazide 25 mg/1 Tablet | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 0615-8344 | Hydrochlorothiazide 12.5 mg/1 Capsule | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8449 | Hydrochlorothiazide 12.5 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8450 | Hydrochlorothiazide 25 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-522 | Hydrochlorothiazide 12.5 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-616 | Hydrochlorothiazide 12.5 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-088 | Hydrochlorothiazide 25 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-272 | Hydrochlorothiazide 25 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-422 | Hydrochlorothiazide 50 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-502 | Hydrochlorothiazide 12.5 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-506 | Hydrochlorothiazide 50 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-674 | Hydrochlorothiazide 12.5 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-831 | Hydrochlorothiazide 25 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-515 | Hydrochlorothiazide 25 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 82868-016 | Hydrochlorothiazide 50 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 66267-106 | Hydrochlorothiazide 25 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3323 | Hydrochlorothiazide 50 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-4963 | Hydrochlorothiazide 25 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5211 | Hydrochlorothiazide 25 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4933 | Hydrochlorothiazide 25 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2405 | Hydrochlorothiazide 50 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2411 | Hydrochlorothiazide 25 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3443 | Hydrochlorothiazide 12.5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3608 | Hydrochlorothiazide 12.5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3652 | Hydrochlorothiazide 12.5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4819 | Hydrochlorothiazide 25 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 69584-361 | Hydrochlorothiazide 25 mg/1 Tablet | Oxford Pharmaceuticals, LLC | ANDA |
| 69584-362 | Hydrochlorothiazide 50 mg/1 Tablet | Oxford Pharmaceuticals, LLC | ANDA |
| 72789-303 | Hydrochlorothiazide 50 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-296 | Hydrochlorothiazide 25 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-176 | Hydrochlorothiazide 12.5 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-747 | Hydrochlorothiazide 50 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-381 | Hydrochlorothiazide 25 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-512 | Hydrochlorothiazide 25 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-7790 | Hydrochlorothiazide 50 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8517 | Hydrochlorothiazide 25 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8813 | Hydrochlorothiazide 12.5 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8862 | Hydrochlorothiazide 12.5 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7683 | Hydrochlorothiazide 12.5 mg/1 Capsule | Preferred Pharmaceuticals, Inc. | ANDA |
| 82804-973 | Hydrochlorothiazide 50 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-793 | Hydrochlorothiazide 25 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-751 | Hydrochlorothiazide 50 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-589 | Hydrochlorothiazide 12.5 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-419 | Hydrochlorothiazide 25 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-161 | Hydrochlorothiazide 12.5 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-090 | Hydrochlorothiazide 50 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-980 | Hydrochlorothiazide 12.5 mg/1 Capsule | Proficient Rx LP | ANDA |
| 82804-031 | Hydrochlorothiazide 50 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-553 | Hydrochlorothiazide 12.5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-441 | Hydrochlorothiazide 50 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-440 | Hydrochlorothiazide 25 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-367 | Hydrochlorothiazide 25 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-972 | Hydrochlorothiazide 25 mg/1 Tablet | Proficient Rx LP | ANDA |
| 42708-164 | Hydrochlorothiazide 25 mg/1 Tablet | QPharma Inc | ANDA |
| 42708-086 | Hydrochlorothiazide 12.5 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-028 | Hydrochlorothiazide 25 mg/1 Tablet | QPharma, Inc. | ANDA |
| 42708-079 | Hydrochlorothiazide 25 mg/1 Tablet | QPharma, Inc. | ANDA |
| 35356-807 | Hydrochlorothiazide 12.5 mg/1 Capsule | Quality Care Products LLC | ANDA |
| 67296-2043 | Hydrochlorothiazide 25 mg/1 Tablet | Redpharm drug | ANDA |
| 67296-2280 | Hydrochlorothiazide 25 mg/1 Tablet | Redpharm Drug | ANDA |
| 70518-4525 | Hydrochlorothiazide 50 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2550 | Hydrochlorothiazide 12.5 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3749 | Hydrochlorothiazide 25 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3780 | Hydrochlorothiazide 50 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4113 | Hydrochlorothiazide 25 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4251 | Hydrochlorothiazide 12.5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4359 | Hydrochlorothiazide 25 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4466 | Hydrochlorothiazide 12.5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4736 | Hydrochlorothiazide 12.5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 57237-002 | Hydrochlorothiazide 12.5 mg/1 Capsule | Rising Pharma Holdings, Inc. | ANDA |
| 50228-146 | Hydrochlorothiazide 12.5 mg/1 Capsule | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-112 | Hydrochlorothiazide 50 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-111 | Hydrochlorothiazide 25 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 43547-398 | Hydrochlorothiazide 50 mg/1 Tablet | Solco Healthcare U.S., LLC | ANDA |
| 43547-397 | Hydrochlorothiazide 25 mg/1 Tablet | Solco Healthcare U.S., LLC | ANDA |
| 60760-662 | Hydrochlorothiazide 12.5 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-315 | Hydrochlorothiazide 25 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA |
| 0172-2089 | Hydrochlorothiazide 50 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0172-3444 | Hydrochlorothiazide 12.5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0172-2083 | Hydrochlorothiazide 25 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 29300-485 | Hydrochlorothiazide 12.5 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-130 | Hydrochlorothiazide 12.5 mg/1 Capsule | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-129 | Hydrochlorothiazide 50 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-128 | Hydrochlorothiazide 25 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 87441-038 | Hydrochlorothiazide 25 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA |
| 69367-219 | Hydrochlorothiazide 12.5 mg/1 Capsule | Westminster Pharmaceuticals, LLC | ANDA |
| 0591-0347 | Hydrochlorothiazide 12.5 mg/1 Capsule, Gelatin Coated | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC |
| 67544-739 | Hydrochlorothiazide 12.5 mg/1 Capsule, Gelatin Coated | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC |
| 63187-548 | Hydrochlorothiazide 12.5 mg/1 Capsule, Gelatin Coated | Proficient Rx LP | NDA AUTHORIZED GENERIC |
| 42708-027 | Hydrochlorothiazide 12.5 mg/1 Capsule, Gelatin Coated | QPharma, Inc. | NDA AUTHORIZED GENERIC |
Hydrochlorothiazide recalls
- D-1206-2018 Sep 19, 2018 · Class I · Terminated
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg. - D-1352-2015 Sep 2, 2015 · Class II · Terminated
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Frequently asked questions
What is Hydrochlorothiazide used for?
Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of…
What are the side effects of Hydrochlorothiazide?
The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the order of… See the full label for the complete list.
Who makes Hydrochlorothiazide?
Hydrochlorothiazide is listed by 44 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., Actavis Pharma, Inc., Alembic Pharmaceuticals Inc..
Has Hydrochlorothiazide been recalled?
The FDA enforcement database lists 2 recalls for Hydrochlorothiazide, most recently D-1206-2018 (class i): Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.