Prescription medicine
Hydrochlorothiazide and valsartan Brand names: Diovan; first approved as Diovan Hct
Hydrochlorothiazide and valsartan (Diovan) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.101 per valsartan-hydrochlorothiazide 160-12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the hydrochlorothiazide and valsartan FDA label on DailyMed (effective February 13, 2026, Novartis Pharmaceuticals Corporation); the NDA 20818 record on Drugs@FDA; every hydrochlorothiazide and valsartan label on DailyMed.
Highlights of the record
FDA label of February 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue Diovan HCT as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Diovan HCT as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageDiovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 12.5 mg / 80 mg
- 12.5 mg / 320 mg
- 12.5 mg / 160 mg
- 25 mg / 320 mg
- 25 mg / 160 mg
- 80 mg / 12.5 mg
- 160 mg / 12.5 mg
- 160 mg / 25 mg
- 320 mg / 25 mg
- 320 mg / 12.5 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- March 6, 1998 Diovan Hct, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first September 21, 2012; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 18 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.101 per tablet Valsartan-hydrochlorothiazide 160-12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 23 since 2018 0 Class I among all firms' recalls; latest December 31, 2018
- FAERS reports
- 13,500 through July 30, 2026
What is hydrochlorothiazide and valsartan used for?
From the label: indications and usageDiovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. […]
Conditions named in the indications of hydrochlorothiazide and valsartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Thiazide Diuretic.
Source: FDA drug label (Diovan HCT), Novartis Pharmaceuticals Corporation, effective February 13, 2026 (SPL set d76a0419-05ee-437e-884c-65807aea9569), via openFDA; the full label on DailyMed
What does the patient leaflet for hydrochlorothiazide and valsartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DIOVAN HCT?DIOVAN HCT can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking DIOVAN HCT, tell your doctor right away.
From the patient leaflet: What should I avoid while taking DIOVAN HCT?You should not take DIOVAN HCT during pregnancy. See “What is the most important information I should know about DIOVAN HCT?”
Source: FDA drug label (Diovan HCT), Novartis Pharmaceuticals Corporation, effective February 13, 2026 (SPL set d76a0419-05ee-437e-884c-65807aea9569), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide and valsartan (Diovan)?
The FDA approved the first generic hydrochlorothiazide and valsartan on September 21, 2012. 11 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists hydrochlorothiazide and valsartan from 18 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2012 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 hydrochlorothiazide and valsartan (Diovan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.101 per Valsartan-hydrochlorothiazide 160-12.5 mg tablet, down 30% from $0.145 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. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Valsartan-hydrochlorothiazide 80-12.5 mg tablet (generic)
- Diovan hct 80-12.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Valsartan-hydrochlorothiazide 160-12.5 mg tablet | Generic | $0.101 per tablet | $3.04 | -30% |
| Valsartan-hydrochlorothiazide 160-25 mg tablet | Generic | $0.121 per tablet | $3.64 | -25% |
| Valsartan-hydrochlorothiazide 320-12.5 mg tablet | Generic | $0.186 per tablet | $5.58 | -19% |
| Valsartan-hydrochlorothiazide 320-25 mg tablet | Generic | $0.192 per tablet | $5.75 | -8% |
| Valsartan-hydrochlorothiazide 80-12.5 mg tablet | Generic | $0.0973 per tablet | $2.92 | -32% |
| Diovan hct 160-12.5 mg tablet | Brand | $11.48 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $344.29 | +3% |
| Diovan hct 320-25 mg tablet | Brand | $16.38 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $491.39 | +2% |
| Diovan hct 80-12.5 mg tablet | Brand | $10.56 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $316.94 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has hydrochlorothiazide and valsartan been recalled?
The FDA's Enforcement Report lists 23 recalls naming hydrochlorothiazide and valsartan since 2018: 0 Class I (the most serious), 23 Class II, 0 Class III; 23 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 31, 2018 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim … |
| December 4, 2018 | Class II | Mylan Laboratories Limited, (Nashik FDF) | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| November 20, 2018 | Class II | Mylan Pharmaceuticals Inc. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. |
| July 17, 2018 | Class II | A-S Medication Solutions LLC. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
| July 16, 2018 | Class II | Teva Pharmaceuticals USA | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
| July 13, 2018 | Class II | Prinston Pharmaceutical Inc | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrochlorothiazide and valsartan label say about other medicines?
The hydrochlorothiazide and valsartan 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 |
|---|---|---|
| Aliskiren | contraindications | Do not coadminister aliskiren with Diovan HCT in patients with diabetes [see Drug Interactions (7)]. |
| Amiloride | drug interactions | Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g. … |
| Carbamazepine | drug interactions | Carbamazepine – May lead to symptomatic hyponatremia. |
| Cholestyramine | drug interactions | Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. ( 7 ) Cholestyramine and colestipol: |
| Colestipol | drug interactions | Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. ( 7 ) Cholestyramine and colestipol: |
| Cyclosporine | drug interactions | Cyclosporine: Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications. |
| Heparin | drug interactions | … supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. |
| Lithium | drug interactions | DRUG INTERACTIONS Valsartan-Hydrochlorothiazide: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. |
| Spironolactone | drug interactions | Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g. … |
| Triamterene | drug interactions | Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g. … |
Check hydrochlorothiazide and valsartan against other medicines
Source: FDA drug label (Diovan HCT), Novartis Pharmaceuticals Corporation, effective February 13, 2026 (SPL set d76a0419-05ee-437e-884c-65807aea9569), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide and valsartan?
The FDA Adverse Event Reporting System holds 13,500 reports that list hydrochlorothiazide and valsartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,383 are coded as a death and 4,201 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.
Reports received each year
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 hydrochlorothiazide and valsartan?
55 other medicines are given the same way (oral) and in the same FDA class as hydrochlorothiazide and valsartan 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 |
|---|---|---|---|---|
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 mg tablet | No current entry |
| Irbesartan | High blood pressure | 23 labelers | $0.107 per tablet 150 mg tablet | No current entry |
| Telmisartan | High blood pressure | 28 labelers | $0.106 per tablet 20 mg tablet | No current entry |
| Amlodipine and olmesartan | High blood pressure | 14 labelers | $0.248 per unit 10-20 mg | No current entry |
| Candesartan | High blood pressure | 8 labelers | $0.478 per tablet 16 mg tablet | No current entry |
| Amlodipine and telmisartan | High blood pressure | 3 labelers | $2.88 per unit 40-10 | No current entry |
| Azilsartan | High blood pressure | 1 labeler | $5.47 per tablet 40 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydrochlorothiazide and valsartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydrochlorothiazide and valsartan
- 55 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide and valsartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other