Prescription medicine
Valsartan Brand names: Diovan, Prexxartan
Valsartan (Diovan) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 34 generic labelers, and pharmacies paid $0.0963 per valsartan 40 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the valsartan FDA label on DailyMed (effective August 5, 2026, Macleods Pharmaceuticals Limited); the NDA 20665 record on Drugs@FDA; every valsartan label on DailyMed.
Highlights of the record
FDA label of August 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY •.
When pregnancy is detected, discontinue valsartan tablets 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 valsartan tablets 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 usageValsartan tablets are an angiotensin II receptor blocker (ARB) indicated for:
Hypertension, to lower blood pressure in adults and children 6 years and older.
Forms and strengths
- 40 mg
- 80 mg
- 160 mg
- 320 mg
- 4 mg/ml
Film-coated tablet; tablet; solution.
On the market
- Earliest approval on file
- December 23, 1996 Diovan, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first June 26, 2014; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 36 of which 34 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0963 per tablet Valsartan 40 mg tablet
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 58 since 2013 0 Class I among all firms' recalls; latest August 4, 2026; 4 more by firms not listed as its makers
- FAERS reports
- 104,490 through July 30, 2026
What is valsartan used for?
From the label: indications and usageValsartan tablets are an angiotensin II receptor blocker (ARB) indicated for:
Hypertension, to lower blood pressure in adults and children 6 years and older. […]
Conditions named in the indications of valsartan's FDA labels, with every medicine labeled for each:
From other valsartan labelsHigh blood pressure: Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older.
Heart failure: Valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (NYHA class II-IV).
FDA pharmacologic class: Angiotensin 2 Receptor Blocker.
Source: FDA drug label (Valsartan), Macleods Pharmaceuticals Limited, effective August 5, 2026 (SPL set 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 valsartan tablets?Valsartan tablets can cause harm or death to an unborn baby. • Talk to your healthcare provider about other ways to lower your blood pressure if you plan to become pregnant. • If you become pregnant during treatment with valsartan tablets, stop taking valsartan tablets and tell your healthcare provider right away.
From the patient leaflet: How should I store valsartan tablets?Store valsartan tablets at room temperature between 68ºF to 77ºF (20ºC to 25 ºC). • Keep valsartan tablets container tightly closed and in a dry place to protect from moisture. • Valsartan suspension is provided in a glass bottle with a child-resistant screw-cap closure. • Store bottles of valsartan suspension at room temperature less than 86ºF (30ºC) for up to 30 days, or refrigerate between 35ºF to 46ºF (2ºC to 8ºC) for up to 75 days. Keep valsartan tablets and all medicines out of the reach of children.
Source: FDA drug label (Valsartan), Macleods Pharmaceuticals Limited, effective August 5, 2026 (SPL set 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46), via openFDA; the full label on DailyMed
Is there a generic for valsartan (Diovan)?
The FDA approved the first generic valsartan on June 26, 2014. 24 generic applications are approved; 18 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 valsartan from 34 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2014 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 valsartan (Diovan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0963 per Valsartan 40 mg tablet, down 21% from $0.122 on October 8, 2025. 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 40 mg tablet (generic)
- Diovan 40 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Valsartan 160 mg tablet | Generic | $0.106 per tablet | $3.18 | -28% |
| Valsartan 320 mg tablet | Generic | $0.163 per tablet | $4.90 | -18% |
| Valsartan 40 mg tablet | Generic | $0.0963 per tablet | $2.89 | -21% |
| Valsartan 80 mg tablet | Generic | $0.082 per tablet | $2.46 | -35% |
| Diovan 160 mg tablet | Brand | $10.04 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $301.13 | +2% |
| Diovan 320 mg tablet | Brand | $12.67 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $380.23 | +3% |
| Diovan 40 mg tablet | Brand | $7.82 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $234.49 | +3% |
| Diovan 80 mg tablet | Brand | $9.33 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $279.81 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is valsartan in shortage?
No valsartan presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated November 19, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Valsartan, Tablet, 160 mg (NDC 0378-5814-77) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | November 19, 2025 |
| Valsartan, Tablet, 320 mg (NDC 0378-5815-77) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | November 19, 2025 |
| Valsartan, Tablet, 40 mg (NDC 0378-5807-93) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | November 19, 2025 |
| Valsartan, Tablet, 80 mg (NDC 0378-5813-77) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | November 19, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has valsartan been recalled?
The FDA's Enforcement Report lists 62 recalls naming valsartan since 2013: 0 Class I (the most serious), 57 Class II, 5 Class III; 31 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of valsartan and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 4, 2026 | Class II | Novartis Pharmaceuticals Corporation | Failed Dissolution Specifications |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| March 7, 2019 | Class II | Rising Pharmaceuticals, Inc. | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products |
| March 6, 2019 | Class II | American Health Packaging | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. |
| 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 31, 2018 | Class II | Aurobindo Pharma USA Inc. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| 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. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the valsartan label say about other medicines?
The valsartan label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name valsartan. 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 valsartan in patients with diabetes [see Drug Interactions ( 7.3 )]. |
| Amiloride | drug interactions | 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., heparin) may lead to increases in … |
| 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 | Increases in serum lithium level and lithium toxicity |
| Spironolactone | drug interactions | 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., heparin) may lead to increases in … |
| Triamterene | drug interactions | 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., heparin) may lead to increases in … |
Other labels that name valsartan
Source: FDA drug label (Valsartan), Macleods Pharmaceuticals Limited, effective August 5, 2026 (SPL set 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46), via openFDA; the full label on DailyMed
What do FAERS reports show for valsartan?
The FDA Adverse Event Reporting System holds 104,490 reports that list valsartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,543 are coded as a death and 39,227 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 valsartan?
76 other medicines are given the same way (oral) and in the same FDA class as 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 |
| Hydrochlorothiazide and losartan | High blood pressure | 29 labelers | $0.0762 per tablet 100-12.5 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 |
| Hydrochlorothiazide and olmesartan | High blood pressure | 17 labelers | $0.165 per tablet 20-12.5 mg tablet | No current entry |
| Amlodipine and olmesartan | High blood pressure | 14 labelers | $0.248 per unit 10-20 mg | No current entry |
| Amlodipine and hydrochlorothiazide and olmesartan | High blood pressure | 8 labelers | $0.776 per unit 20-5-12.5 | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does valsartan compare with medicines for the same use?
22 side-by-side pages set valsartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to valsartan
- 76 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Valsartan side effects
- the label's list beside FAERS reports
- Valsartan shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other