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Valsartan 320 mg Tablet, 30-count — NDC 63187-655-30 (Billing 63187-0655-30)

by Proficient Rx LP · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Valsartan 320 mg Tablet from Proficient Rx LP, marketed since Aug 2015 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 63187-0655-30
🏷️ FDA NDC (as labeled) 63187-655-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2655/unit — full pricing hub ↓
Main listing for product 63187-655 · Also comes in: 60 tablets 63187-655-60 90 tablets 63187-655-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Valsartan (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 4, 2026 — Failed Dissolution Specifications (Novartis Pharmaceuticals Corporation) · FDA recall D-0746-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-655-30
Product NDC 63187-655
11-digit billing NDC 63187065530
RxCUI 349200
UNII 80M03YXJ7I
Application # ANDA204821
SPL Set ID b58471fe-e2c6-4cc5-9d49-6a3111f6e002
Established class (EPC) Angiotensin 2 Receptor Blocker
Mechanism of action Angiotensin 2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-08-31
Route ORAL
Dosage form TABLET
Substance VALSARTAN
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 349200
Why two NDCs? The FDA registers this code as 63187-655-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0655-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker
Drug family (ATC) Angiotensin II receptor blockers (ARBs), plain, Angiotensin II receptor blockers (ARBs) and calcium channel blockers
How it works Angiotensin 2 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Valsartan is mainly used to treat high blood pressure, which helps lower your risk of stroke and heart attack. It's also used in adults with heart failure to reduce the chance of b...
  • Yes — valsartan tablets can be taken with or without food, so whatever works best for your routine is fine. If you're taking the oral solution, take it as directed by your prescrib...
  • Can I take valsartan with or without food?
  • Most people do well on valsartan. The most common issues are headache, dizziness, and fatigue. If you feel faint or lightheaded — especially when standing up — that can be a sign y...
📖 Read our full Valsartan guide →
1
Nutrient depletion considerations

Valsartan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Valsartan nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2655 $7.97 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0655-30 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2018-12-01 — Active
63187-0655-60 63187-655-60 60 TABLET in 1 BOTTLE 2018-12-01 — Active
63187-0655-90 63187-655-90 90 TABLET in 1 BOTTLE 2018-12-01 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 63187-0655-60?
Both are Valsartan 320 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 63187-0655-60 is the 60 tablets package.
What NDC number is used to bill for this package of Valsartan 320 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Valsartan 320 mg 00378-5815-77 Mylan 90 tablets $0.163 AB Availability likely —
Valsartan 320 mg 33342-0065-10 Macleods 90 tablets $0.163 AB Availability likely —
Valsartan 320 mg 50268-0749-13 AvPAK 1 tablet $0.163 AB Availability likely —
Valsartan 320 mg 65162-0840-09 Amneal 90 tablets $0.163 AB Availability likely —
Valsartan 320 mg 72578-0134-16 Viona 90 tablets $0.163 AB Availability likely —
Valsartan 320 mg 72819-0184-09 Archis 90 tablets $0.165 AB Discontinued —
Diovan 320 mg 00078-0360-34 Novartis 90 tablets $12.674 AB Availability likely —
Diovan 320 mg 00078-1259-34 Novartis 90 tablets — AB FDA listed —
Valsartan 320 mg 29300-0235-10 Unichem 1000 tablets — — FDA listed —
Valsartan 320 mg 31722-0154-05 Camber 500 tablets — AB FDA listed —
Valsartan 320 mg 31722-0748-05 Camber 500 tablets — AB FDA listed —
Valsartan 320 mg 42291-0859-90 AvKARE 90 tablets — AB FDA listed —
Valsartan 320 mg 42385-0992-05 Laurus 500 tablets — AB FDA listed —
Valsartan 320 mg 43547-0370-03 Solco 30 tablets — AB FDA listed —
Valsartan 320 mg 46708-0047-30 Alembic 30 tablets — AB FDA listed —
valsartan 320 mg 50090-5192-00 A-S 30 tablets — AB FDA listed —
Valsartan 320 mg 50090-6346-00 A-S 30 tablets — AB FDA listed —
Valsartan 320 mg 50090-7312-00 A-S 30 tablets — AB FDA listed —
Valsartan 320 mg 50228-0132-05 ScieGen 500 tablets — AB FDA listed —
Valsartan 320 mg 51660-0143-03 Ohm 10 tablets — AB FDA listed —
Valsartan 320 mg 53746-0840-05 Amneal 500 tablets — AB FDA listed —
Valsartan 320 mg 55111-0734-01 Dr. 100 tablets — AB FDA listed —
valsartan 320 mg 59746-0363-62 Jubilant 90 tablets — AB FDA listed —
Valsartan 320 mg 62332-0047-30 Alembic 30 tablets — AB FDA listed —
Valsartan 320 mgthis 63187-0655-30 Proficient 30 tablets — AB FDA listed —
Valsartan 320 mg 65862-0573-05 Aurobindo 500 tablets — — FDA listed —
Valsartan 320 mg 67046-1574-03 Coupler 30 tablets — AB FDA listed —
Valsartan 320 mg 67877-0418-05 Ascend 500 tablets — AB FDA listed —
Valsartan 320 mg 70771-1885-09 Zydus 90 tablets — AB FDA listed —
Valsartan 320 mg 71205-0301-30 Proficient 30 tablets — AB FDA listed —
Valsartan 320 mg 71335-0475-01 Bryant 30 tablets — AB FDA listed —
Valsartan 320 mg 71335-2155-01 Bryant 30 tablets — AB FDA listed —
Valsartan 320 mg 76483-0025-00 SQUARE 30 tablets — AB FDA listed —
Valsartan 320 mg 50090-4130-00 A-S 30 tablets — AB FDA listed —
valsartan 320 mg 59746-0393-30 Jubilant 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Aug 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Brown
ShapeCapsule
ImprintHH;344
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA204821 (ANDA)
Labeler code63187
First marketedAug 2015
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 84 words ▾

WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue valsartan 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 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 )

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension , to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) • Treatment of heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure ( 1.2 ) • Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction ( 1.3 )

1.1Hypertension Valsartan tablets are 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 the class to which valsartan principally belongs.

There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.

The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Valsartan tablets may be used alone or in combination with other antihypertensive agents.

1.2Heart Failure Valsartan tablets are indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, valsartan tablets significantly reduced hospitalizations for heart failure. There is no evidence that valsartan tablets provide added benefits when it is used with an adequate dose of an ACE inhibitor [ see Clinical Studies (14.2) ].

1.3Post-Myocardial Infarction In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce cardiovascular mortality [ see Clinical Studies (14.3) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range Target Maintenance Dose* Adult Hypertension ( 2.1 ) 80 or 160 mg once daily 80-320 mg once daily --- Pediatric Hypertension (6-16 years) ( 2.2 ) 1.3 mg/kg once daily (up to 40 mg total) 1.3-2.7 mg/kg once daily (up to 40-160 mg total) --- Heart Failure ( 2.3 ) 40 mg twice daily 40-160 mg twice daily 160 mg twice daily Post-Myocardial Infarction ( 2.4 ) 20 mg twice daily 20-160 mg twice daily 160 mg twice daily * as tolerated by patient

2.1Adult Hypertension The recommended starting dose of valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.

The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of valsartan in patients with hepatic or severe renal impairment. Valsartan may be administered with other antihypertensive agents.

Valsartan may be administered with or without food.

2.2Pediatric Hypertension 6 to 16 Years of Age For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been studied in pediatric patients 6 to 16 years old.

For children who cannot swallow tablets, or children for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths of valsartan, the use of a suspension is recommended. Follow the suspension preparation instructions below (see Preparation of Suspension ) to administer valsartan as a suspension. When the suspension is replaced by a tablet, the dose of valsartan may have to be increased.

The exposure to valsartan with the suspension is 1.6 times greater than with the tablet. No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m 2 [ see Pediatric Use (8.4) ]. Valsartan is not recommended for patients <6 years old [ see Adverse Reactions (6.1) , Clinical Studies (14.1) ].

Preparation of Suspension (for 160 mL of a 4 mg/mL suspension) Add 80 mL of Ora-Plus ® * oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets, and shake for a minimum of 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute.

Add 80 mL of Ora-Sweet SF ® * oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30 o C/86 o F) or up to 75 days at refrigerated conditions (2-8 o C/35-46 o F) in the glass bottle with a child-resistant screw-cap closure. Shake the bottle well (at least 10 seconds) prior to dispensing the suspension. *Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc.

2.3Heart Failure The recommended starting dose of valsartan is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.

2.4Post-Myocardial In… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 99 words ▾

3 DOSAGE FORMS AND STRENGTHS 40 mg are scored yellow, capsule-shaped, biconvex, film-coated tablets debossed with “341” and bisect between 3 and 41 on one side, and “HH” on the other side. 80 mg are brown, capsule-shaped, biconvex, film-coated tablets debossed with “342” on one side and “HH” on the other side. 160 mg are yellow, capsule-shaped, biconvex, film-coated tablets debossed with “343” on one side and “HH” on the other side.

320 mg are brown, capsule-shaped, biconvex, film-coated tablets debossed with “344” on one side and “HH” on the other side. Tablets (mg): 40 (scored), 80, 160, 320

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan in patients with diabetes [ see Drug Interactions (7) ]. Known hypersensitivity to any component; Do not coadminister aliskiren with valsartan in patients with diabetes ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Observe for signs and symptoms of hypotension ( 5.2 ) • Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 )

5.1Fetal Toxicity Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

When pregnancy is detected, discontinue valsartan as soon as possible. [ see Use in Specific Populations (8.1) ].

5.2Hypotension Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision.

Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction patients. Patients with heart failure or post-myocardial infarction patients given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients.

In the Valsartan in Acute Myocardial Infarction Trial (VALIANT), hypotension in post-myocardial infarction patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients. If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients.

Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on valsartan [ see Drug Interactions (7) ].

5.4Hyperkalemia Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of valsartan may be required [ see Adverse Reactions (6.1) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Valsartan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.

The overall incidence of adverse reactions with valsartan was similar to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients.

The most common reasons for discontinuation of therapy with valsartan were headache and dizziness. The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with valsartan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs.

1%), and abdominal pain (2% vs. 1%). Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and valsartan patients.

In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p <0.001). Dose-related orthostatic effects were seen in less than 1% of patients.

An increase in the incidence of dizziness was observed in patients treated with valsartan 320 mg (8%) compared to 10 to 160 mg (2% to 4%). Valsartan has been used concomitantly with hydrochlorothiazide without evidence of clinically important adverse interactions. Other adverse reactions that occurred in controlled clinical trials of patients treated with valsartan (>0.2% of valsartan patients) are listed below.

It cannot be determined whether these events were causally related to valsartan. Body as a Whole: Allergic reaction and asthenia Cardiovascular: Palpitations Dermatologic: Pruritus and rash Digestive: Constipation, dry mouth, dyspepsia, and flatulence Musculoskeletal: Back pain, muscle cramps, and myalgia Neurologic and Psychiatric: Anxiety, insomnia, paresthesia, and somnolence Respiratory: Dyspnea Special Senses: Vertigo Urogenital: Impotence Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.

Pediatric Hypertension Valsartan has been evaluated for safety in over 400 pediatric patients aged 6 to 17 years and more than 160 pediatric patients aged 6 months to 5 years. No relevant differences were identified between the adverse experience profile for pediatric patients aged 6 to 16 years and that previously reported f… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS No clinically significant pharmacokinetic interactions were observed when valsartan was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone. Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin.

CYP 450 Interactions: In vitro metabolism studies indicate that CYP 450 mediated drug interactions between valsartan and coadministered drugs are unlikely because of the low extent of metabolism [ see Clinical Pharmacology (12.3) ]. Transporters: The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Coadministration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.

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., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable. Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including valsartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy [ see Clinical Trials 14.3 ]. In general, avoid combined use of RAS inhibitors.

Closely monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the RAS. Do not coadminister aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR <60 mL/min).

Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including valsartan. Monitor serum lithium levels during concomitant use. • Potassium sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine ( 7 ) • NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7 ) • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7 ) • Lithium: Increases in serum lithium concentrations and lithium toxicity ( 7 )

7.1Clinical Laboratory Test Findings In controlled clinical trials, clinically important changes in standard laboratory parameters w… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Nursing or drug should be discontinued ( 8.3 ); Pediatrics : Efficacy and safety data support use in 6-16 year old patients; use is not recommended in patients <6 years old ( 6.1 , 8.4 )

8.1Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

When pregnancy is detected, discontinue valsartan as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.

If oligohydramnios is observed, discontinue valsartan, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

Closely observe infants with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia [ see Use in Specific Populations (8.4) ].

8.3Nursing Mothers It is not known whether valsartan is excreted in human milk. Valsartan was excreted in the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from valsartan, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use The antihypertensive effects of valsartan have been evaluated in two randomized, double-blind clinical studies in pediatric patients from 1-5 and 6-16 years of age [ see Clinical Studies (14.1) ]. The pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [ see Pharmacokinetics, Special Populations, Pediatric (12.3) ]. Valsartan was generally well tolerated in children 6-16 years and the adverse experience profile was similar to that described for adults.

In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. Valsartan is not recommended for pediatric patients under 6 years of age due to safety findings for which a relationship to treatment could not be excluded [ see Adverse Reactions, Pediatric Hypertension (6.1) ]. No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m 2 .

There is limited clinical experience with valsartan in pediatric patients with mild to moderate hepatic impairment [ see Warnings and Precautions (5.3) ] . Daily oral dosing of neonatal/juvenile rats with valsartan at doses as low as 1 mg/kg/day (about 10% of the maximum recommended pediatric dose on a mg/m 2 basis) from postnatal day 7 to postnatal day 70 produced persistent, irreversible kidney damage. These kidney effects in neonatal rats represent expected exaggerated pharm… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 127 words ▾

10 OVERDOSAGE Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported.

If symptomatic hypotension should occur, supportive treatment should be instituted. Valsartan is not removed from the plasma by hemodialysis. Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the maximum recommended human dose on a mg/m 2 basis).

(Calculations assume an oral dose of 320 mg/day and a 60-kg patient.)

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.

Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT 1 receptor than for the AT 2 receptor.

The increased plasma levels of angiotensin II following AT 1 receptor blockade with valsartan may stimulate the unblocked AT 2 receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT 1 receptor about one-200th that of valsartan itself. Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension.

ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known.

Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.

12.2Pharmacodynamics Valsartan inhibits the pressor effect of angiotensin II infusions. An oral dose of 80 mg inhibits the pressor effect by about 80% at peak with approximately 30% inhibition persisting for 24 hours. No information on the effect of larger doses is available.

Removal of the negative feedback of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients. Minimal decreases in plasma aldosterone were observed after administration of valsartan; very little effect on serum potassium was observed. In multiple-dose studies in hypertensive patients with stable renal insufficiency and patients with renovascular hypertension, valsartan had no clinically significant effects on glomerular filtration rate, filtration fraction, creatinine clearance, or renal plasma flow.

In multiple-dose studies in hypertensive patients, valsartan had no notable effects on total cholesterol, fasting triglycerides, fasting serum glucose, or uric acid.

12.3Pharmacokinetics Valsartan peak plasma concentration is reached 2 to 4 hours after dosing. Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours. Absolute bioavailability for valsartan is about 25% (range 10% to 35%).

The bioavailability of the suspension [ see Dosage and Administration; Pediatric Hypertension (2.2) ] is 1.6 times greater than with the tablet. With the tablet, food decreases the exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (C max ) by about 50%. AUC and C max values of valsartan increase approximately linearly with increasing dose over the clinical dosing range.

Valsartan does not accumulate appreciably in plasma following repeated administration. Metabolism and Elimination: Valsartan, when administered as an oral solution, is primarily recover… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Valsartan tablets, USP, are available as tablets containing valsartan 320 mg. 320 mg tablets are unscored and biconvex and capsule-shaped. Bottle of 30 NDC 63187-655-30 Bottle of 60 NDC 63187-655-60 Bottle of 90 NDC 63187-655-90 Store at 20-25 o C (68-77 o F); excursions permitted to 15-30 o C (59-86 o F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

📋 Description 130 words ▾

11 DESCRIPTION Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is: Valsartan is a white to practically white fine powder.

It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, polyvinyl alcohol-partially hydrolyzed, iron oxides (yellow and/or red), magnesium stearate, microcrystalline cellulose, macrogol/PEG 3350, talc, and titanium dioxide.

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💬 Information for Patients 93 words ▾

17 PATIENT COUNSELING INFORMATION Information for Patients Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to valsartan during pregnancy. Discuss treatment options with women planning to become pregnant.

Patients should be asked to report pregnancies to their physicians as soon as possible. Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512, USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 10/2015 17016-02

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Valsartan Tablets (val-SAR-tan), USP Read the Patient Information that comes with valsartan before you take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

If you have any questions about valsartan, ask your doctor or pharmacist. What is the most important information I should know about valsartan? Valsartan 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 valsartan, tell your doctor right away. What is valsartan?

Valsartan is a prescription medicine called an angiotensin receptor blocker (ARB). It is used in adults to: • lower high blood pressure (hypertension) in adults and children, 6 to 16 years of age. • treat heart failure in adults. In these patients, valsartan may lower the need for hospitalization that happens from heart failure. • improve the chance of living longer after a heart attack (myocardial infarction) in adults.

Valsartan is not for children under 6 years of age or children with certain kidney problems. High Blood Pressure (Hypertension). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests.

You have high blood pressure when the force is too much. Valsartan can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure and vision problems. Heart Failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body.

Just walking or moving can make you short of breath, so you may have to rest a lot. Heart Attack (Myocardial Infarction): A heart attack is caused by a blocked artery that results in damage to the heart muscle. What should I tell my doctor before taking valsartan?

Tell your doctor about all your medical conditions including whether you: • have any allergies. See the end of this leaflet for a complete list of ingredients in valsartan. • have a heart condition • have liver problems • have kidney problems • are pregnant or planning to become pregnant. See “What is the most important information I should know about valsartan?” • are breastfeeding.

It is not known if valsartan passes into your breast milk. You and your doctor should decide if you will take valsartan or breastfeed, but not both. Talk with your doctor about the best way to feed your baby if you take valsartan. • have ever had a reaction called angioedema, to another blood pressure medicine.

Angioedema causes swelling of the face, lips, tongue and/or throat, and may cause difficulty breathing. Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take: • other medicines for high blood pressure or a heart problem • water pills (also called “diuretics”) • potassium supplements.

Your doctor may check the amount of potassium in your blood periodically • a salt substitute. Your doctor may check the amount of potassium in your blood periodically • Nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen) • certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan. • Lithium, a medicine used in some types of depression Know the medicines you take.

Keep a list of your medicines with you to show to your doctor and pharmacist when a new medicine is prescribed. Talk to your doctor or pharmacist bef… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Hypertension Adult Hypertension The antihypertensive effects of valsartan were demonstrated principally in 7 placebo-controlled, 4- to 12-week trials (1 in patients over 65 years) of dosages from 10 to 320 mg/day in patients with baseline diastolic blood pressures of 95-115 mmHg. The studies allowed comparison of once-daily and twice-daily regimens of 160 mg/day; comparison of peak and trough effects; comparison (in pooled data) of response by gender, age, and race; and evaluation of incremental effects of hydrochlorothiazide.

Administration of valsartan to patients with essential hypertension results in a significant reduction of sitting, supine, and standing systolic and diastolic blood pressure, usually with little or no orthostatic change. In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs at approximately 2 hours, and maximum reduction of blood pressure is achieved within 6 hours. The antihypertensive effect persists for 24 hours after dosing, but there is a decrease from peak effect at lower doses (40 mg) presumably reflecting loss of inhibition of angiotensin II.

At higher doses, however (160 mg), there is little difference in peak and trough effect. During repeated dosing, the reduction in blood pressure with any dose is substantially present within 2 weeks, and maximal reduction is generally attained after 4 weeks. In long-term follow-up studies (without placebo control), the effect of valsartan appeared to be maintained for up to 2 years.

The antihypertensive effect is independent of age, gender or race. The latter finding regarding race is based on pooled data and should be viewed with caution, because antihypertensive drugs that affect the renin-angiotensin system (that is, ACE inhibitors and angiotensin-II blockers) have generally been found to be less effective in low-renin hypertensives (frequently blacks) than in high-renin hypertensives (frequently whites). In pooled, randomized, controlled trials of valsartan that included a total of 140 blacks and 830 whites, valsartan and an ACE-inhibitor control were generally at least as effective in blacks as whites.

The explanation for this difference from previous findings is unclear. Abrupt withdrawal of valsartan has not been associated with a rapid increase in blood pressure. The blood pressure lowering effect of valsartan and thiazide-type diuretics are approximately additive.

The 7 studies of valsartan monotherapy included over 2,000 patients randomized to various doses of valsartan and about 800 patients randomized to placebo. Doses below 80 mg were not consistently distinguished from those of placebo at trough, but doses of 80, 160 and 320 mg produced dose-related decreases in systolic and diastolic blood pressure, with the difference from placebo of approximately 6-9/3-5 mmHg at 80 to 160 mg and 9/6 mmHg at 320 mg. In a controlled trial the addition of HCTZ to valsartan 80 mg resulted in additional lowering of systolic and diastolic blood pressure by approximately 6/3 and 12/5 mmHg for 12.5 and 25 mg of HCTZ, respectively, compared to valsartan 80 mg alone.

Patients with an inadequate response to 80 mg once daily were titrated to either 160 mg once daily or 80 mg twice daily, which resulted in a comparable response in both groups. In controlled trials, the antihypertensive effect of once-daily valsartan 80 mg was similar to that of once-daily enalapril 20 mg or once-daily lisinopril 10 mg. There are no trials of valsartan demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.

There was essentially no change in heart rate in valsartan-treated patients in controlled trials. Pediatric Hypertension The antihypertensive effects of valsartan were evaluated in two randomized, double-blind clinical studies. In a clinical study involving 261 hypertensive pediatric patients 6 to 16 years of a… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility There was no evidence of carcinogenicity when valsartan was administered in the diet to mice and rats for up to 2 years at doses up to 160 and 200 mg/kg/day, respectively. These doses in mice and rats are about 2.6 and 6 times, respectively, the maximum recommended human dose on a mg/m 2 basis. (Calculations assume an oral dose of 320 mg/day and a 60-kg patient.) Mutagenicity assays did not reveal any valsartan-related effects at either the gene or chromosome level.

These assays included bacterial mutagenicity tests with Salmonella (Ames) and E coli ; a gene mutation test with Chinese hamster V79 cells; a cytogenetic test with Chinese hamster ovary cells; and a rat micronucleus test. Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day. This dose is 6 times the maximum recommended human dose on a mg/m 2 basis.

(Calculations assume an oral dose of 320 mg/day and a 60-kg patient.)

13.2Animal Toxicology and/or Pharmacology Reproductive Toxicology Studies No teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses up to 600 mg/kg/day and to pregnant rabbits at oral doses up to 10 mg/kg/day. However, significant decreases in fetal weight, pup birth weight, pup survival rate, and slight delays in developmental milestones were observed in studies in which parental rats were treated with valsartan at oral, maternally toxic (reduction in body weight gain and food consumption) doses of 600 mg/kg/day during organogenesis or late gestation and lactation.

In rabbits, fetotoxicity (i.e., resorptions, litter loss, abortions, and low body weight) associated with maternal toxicity (mortality) was observed at doses of 5 and 10 mg/kg/day. The no observed adverse effect doses of 600, 200, and 2 mg/kg/day in mice, rats and rabbits represent 9, 6, and 0.1 times, respectively, the maximum recommended human dose on a mg/m 2 basis. Calculations assume an oral dose of 320 mg/day and a 60-kg patient.

📄 Package Label / Principal Display Panel 81 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label-320 mg-90 tablets Rx only NDC 63187-655-90 Valsartan Tablets, USP PHARMACIST: Dispense with the patient information sheet. Each film-coated tablet contains: Valsartan, USP……….320 mg Usual dosage: See packaging insert for complete dosing instructions. Keep this and all drugs out of the reach of children.

Store tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) in this tightly closed container, [See USP Controlled Room Temperature]. Protect from moisture. 63187-655-90

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Valsartan — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Valsartan. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$36.56M
Claims incl. refills
1.4M
Beneficiaries
1.1M
Spend / beneficiary
$32.76
Spend / claim
$25.59
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (63187-0655-60), 90 tablets (63187-0655-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
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