Overview
Hydrochlorothiazide is the most commonly prescribed thiazide diuretic. It is indicated to treat edema and hypertension. Hydrochlorothiazide use is common but declining in favour of angiotensin converting enzyme inhibitors. Many combination products are available containing hydrochlorothiazide and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers. Hydrochlorothiazide was granted FDA approval on 12 February 1959.
Background
Hydrochlorothiazide is the most commonly prescribed thiazide diuretic. It is indicated to treat edema and hypertension. Hydrochlorothiazide use is common but declining in favour of angiotensin converting enzyme inhibitors. Many combination products are available containing hydrochlorothiazide and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers. Hydrochlorothiazide was granted FDA approval on 12 February 1959.
Indication
Hydrochlorothiazide is indicated alone or in combination for the management of edema associated with congestive heart failure, hepatic cirrhosis, nephrotic syndrome, acute glomerulonephritis, chronic renal failure, and corticosteroid and estrogen therapy. Hydrochlorothiazide is also indicated alone or in combination for the management of hypertension.
Associated Conditions
- Calcium Nephrolithiasis
- Cirrhosis of the Liver
- Congestive Heart Failure (CHF)
- Diabetes Insipidus
- Edema
- Hypertension
- Hypertension, Essential Hypertension
- Hypokalemia caused by diuretics
- Nephrotic Syndrome
- Pre-Eclampsia
- Premenstrual tension with edema
- Renal tubular acidosis
- Sodium retention
- Stroke
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/11/11 | Phase 1 | Completed | |||
2016/11/11 | Phase 1 | Completed | |||
2016/08/23 | Phase 4 | Completed | |||
2016/04/20 | Early Phase 1 | Completed | |||
2016/04/15 | Phase 1 | Completed | |||
2016/04/14 | Phase 3 | Completed | |||
2016/03/17 | Not Applicable | Completed | VA New York Harbor Healthcare System | ||
2016/03/16 | Phase 4 | Completed | |||
2016/03/04 | Phase 4 | Completed | |||
2016/01/05 | Phase 4 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvKARE | 42291-925 | ORAL | 12.5 mg in 1 1 | 8/16/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-3001 | ORAL | 12.5 mg in 1 1 | 8/15/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-4376 | ORAL | 25 mg in 1 1 | 2/16/2021 | |
| Lifestar Pharma LLC | 70756-812 | ORAL | 12.5 mg in 1 1 | 12/19/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-747 | ORAL | 50 mg in 1 1 | 9/27/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-4493 | ORAL | 12.5 mg in 1 1 | 2/17/2021 | |
| A-S Medication Solutions | 50090-6736 | ORAL | 50 mg in 1 1 | 8/26/2023 | |
| LUPIN LIMITED | 57297-520 | ORAL | 25 mg in 1 1 | 5/9/2016 | |
| Direct_Rx | 72189-129 | ORAL | 12.5 mg in 1 1 | 6/28/2023 | |
| Sandoz Inc | 0781-5948 | ORAL | 12.5 mg in 1 1 | 3/7/2014 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VALSARTAN HCT SANDOZ FILM-COATED TABLET 80MG/12.5MG | SIN16129P | TABLET, FILM COATED | 12.5 mg | 3/22/2021 | |
| AA-AMILZIDE TABLET | SIN06538P | TABLET | 50 mg | 8/22/1991 | |
| TOLUCOMBI TABLET 80MG/12.5MG | SIN15616P | TABLET | 12.50mg | 1/24/2019 | |
| SARTOCAD H 50/12.5 FILM COATED TABLET 50MG/12.5MG | SIN15421P | TABLET, FILM COATED | 12.5mg | 2/9/2018 | |
| COAPROVEL FILM-COATED TABLET 300/25mg | SIN13546P | TABLET, FILM COATED | 25.00mg | 8/29/2008 | |
| GLIOTENZIDE 20 TABLET | SIN12641P | TABLET | 12.5 mg | 1/14/2005 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hydrochlorothiazide Tablets | 国药准字H14020428 | 化学药品 | 片剂 | 8/31/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H43021198 | 化学药品 | 片剂 | 2/8/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H15020300 | 化学药品 | 片剂 | 7/20/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H11022413 | 化学药品 | 片剂 | 11/27/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H44020999 | 化学药品 | 片剂 | 4/1/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H23021990 | 化学药品 | 片剂(糖衣) | 5/20/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H44020589 | 化学药品 | 片剂 | 5/9/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H44020280 | 化学药品 | 片剂 | 5/6/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H44021722 | 化学药品 | 片剂 | 11/27/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H20033412 | 化学药品 | 片剂 | 10/10/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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