Prescription medicine
Amlodipine and hydrochlorothiazide and valsartan Brand names: Exforge; first approved as Exforge Hct
Amlodipine and hydrochlorothiazide and valsartan (Exforge) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $6.09 per amlodipine-valsartan-hydrochlorothiazide 10-160-25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and hydrochlorothiazide and valsartan FDA label on DailyMed (effective December 12, 2025, Novartis Pharmaceuticals Corporation); the NDA 22314 record on Drugs@FDA; every amlodipine and hydrochlorothiazide and valsartan label on DailyMed.
Highlights of the record
FDA label of December 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue Exforge 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 Exforge 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 usageExforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 5 mg / 160 mg / 25 mg
- 5 mg / 160 mg / 12.5 mg
- 10 mg / 160 mg / 12.5 mg
- 10 mg / 320 mg / 25 mg
- 10 mg / 160 mg / 25 mg
- 10 mg / 25 mg / 320 mg
- 10 mg / 25 mg / 160 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 30, 2009 Exforge Hct, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first September 25, 2012; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $6.09 per tablet Amlodipine-valsartan-hydrochlorothiazide 10-160-25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,689 through July 30, 2026
What is amlodipine and hydrochlorothiazide and valsartan used for?
From the label: indications and usageExforge HCT (amlodipine, valsartan, and hydrochlorothiazide) 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 amlodipine, hydrochlorothiazide, and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT. […]
Conditions named in the indications of amlodipine and hydrochlorothiazide and valsartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker, Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker and Thiazide Diuretic.
Source: FDA drug label (Exforge HCT), Novartis Pharmaceuticals Corporation, effective December 12, 2025 (SPL set 18d7820d-471f-4ee2-9ec6-25d8d27c77de), via openFDA; the full label on DailyMed
What does the patient leaflet for amlodipine and 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 EXFORGE HCT?EXFORGE 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 EXFORGE HCT, tell your doctor right away.
From the patient leaflet: How should I store EXFORGE HCT?Store EXFORGE HCT at room temperature between 59°F and 86°F (15°C and 30°C). Keep EXFORGE HCT dry (protect it from moisture). Keep EXFORGE HCT and all medicines out of the reach of children. General Information about EXFORGE HCT Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use EXFORGE HCT for a condition for which it was not prescribed. Do not give EXFORGE HCT to other people, even if they have the same symptoms that you have. It may harm them. This patient information leaflet summarizes the most important information about EXFORGE HCT. If you would like more information about EXFORGE HCT, talk with your doctor. You can ask your doctor or pharmacist for information about EXFORGE HCT that is written for health professionals. For more information, call 1-888-669-6682.
Source: FDA drug label (Exforge HCT), Novartis Pharmaceuticals Corporation, effective December 12, 2025 (SPL set 18d7820d-471f-4ee2-9ec6-25d8d27c77de), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and hydrochlorothiazide and valsartan (Exforge)?
The FDA approved the first generic amlodipine and hydrochlorothiazide and valsartan on September 25, 2012. 6 generic applications are approved; 3 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 amlodipine and hydrochlorothiazide and valsartan from 5 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.
- 2009 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amlodipine and hydrochlorothiazide and valsartan (Exforge)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.09 per Amlodipine-valsartan-hydrochlorothiazide 10-160-25 mg tablet, down 27% from $8.38 on October 8, 2025. 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.
- Amlodipine-valsartan-hydrochlorothiazide 5-160-25 mg tablet (generic)
- Exforge hct 10-320-25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amlodipine-valsartan-hydrochlorothiazide 10-160-12.5 mg tablet | Generic | $4.94 per tablet | $148.31 | -41% |
| Amlodipine-valsartan-hydrochlorothiazide 10-160-25 mg tablet | Generic | $6.09 per tablet | $182.66 | -27% |
| Amlodipine-valsartan-hydrochlorothiazide 10-320-25 mg tablet | Generic | $5.44 per tablet | $163.30 | -45% |
| Amlodipine-valsartan-hydrochlorothiazide 5-160-12.5 mg tablet | Generic | $4.86 per tablet | $145.84 | -32% |
| Amlodipine-valsartan-hydrochlorothiazide 5-160-25 mg tablet | Generic | $4.24 per tablet | $127.16 | -42% |
| Exforge hct 10-320-25 mg tablet | Brand | $15.45 per tablet | $463.43 | +3% |
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 amlodipine and hydrochlorothiazide and valsartan label say about other medicines?
The amlodipine and hydrochlorothiazide and valsartan label names 13 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 Exforge HCT in patients with diabetes [see Drug Interactions (7)]. |
| Amiloride | drug interactions | Valsartan 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 … |
| Carbamazepine | drug interactions | Carbamazepine: May lead to symptomatic hyponatremia. |
| Cholestyramine | drug interactions | Dosage adjustment of antidiabetic may be required. ( 7 ) Cholestyramine and Colestipol: Reduced absorption of thiazides. |
| Colestipol | drug interactions | Dosage adjustment of antidiabetic may be required. ( 7 ) Cholestyramine and Colestipol: Reduced absorption of thiazides. |
| Cyclosporine | drug interactions | Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. |
| 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 | Valsartan – Hydrochlorothiazide Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. |
| Sildenafil | drug interactions | Sildenafil Monitor for hypotension when sildenafil is coadministered with amlodipine [see Clinical Pharmacology (12.2)]. |
| Simvastatin | drug interactions | Impact of Amlodipine on Other Drugs Simvastatin Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. |
| Spironolactone | drug interactions | Valsartan 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 … |
| Tacrolimus | drug interactions | Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. |
| Triamterene | drug interactions | Valsartan 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 … |
Check amlodipine and hydrochlorothiazide and valsartan against other medicines
Source: FDA drug label (Exforge HCT), Novartis Pharmaceuticals Corporation, effective December 12, 2025 (SPL set 18d7820d-471f-4ee2-9ec6-25d8d27c77de), via openFDA; the full label on DailyMed
What do FAERS reports show for amlodipine and hydrochlorothiazide and valsartan?
The FDA Adverse Event Reporting System holds 3,689 reports that list amlodipine and hydrochlorothiazide and valsartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 505 are coded as a death and 1,014 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 amlodipine and hydrochlorothiazide and valsartan?
49 other medicines are given the same way (oral) and in the same FDA class as amlodipine and 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 |
|---|---|---|---|---|
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Nifedipine | High blood pressure | 32 labelers | $0.130 per tablet 30 mg tablet | No current entry |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 mg tablet | No current entry |
| Verapamil | High blood pressure | 24 labelers | $0.191 per tablet 180 mg tablet | A presentation being discontinued |
| 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 |
| Felodipine | High blood pressure | 14 labelers | $0.123 per tablet 5 mg tablet | No current entry |
Every medicine labeled for the same conditions as amlodipine and hydrochlorothiazide and valsartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amlodipine and hydrochlorothiazide and valsartan
- 49 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Amlodipine and hydrochlorothiazide and valsartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other