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Betaxolol

Betaxolol is a beta-blocker used as a tablet to treat high blood pressure and as eye drops to lower eye pressure in ocular hypertension and chronic open-angle glaucoma.

Brand names KerloneBetoptic S
Drug class Beta-adrenergic Blocker
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Betaxolol at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

On the U.S. market since about 1996 and available as a generic, betaxolol is an older, less commonly used beta-blocker that mainly acts on the heart, taken as a tablet for high blood pressure or as eye drops for glaucoma and high eye pressure, where it reduces the fluid the eye makes. Most people tolerate it reasonably well, noticing at most some tiredness, dizziness or a slower heartbeat. The drops are absorbed into the body too, so both forms can affect the heart and lungs; call promptly about new shortness of breath, swelling, wheezing or fainting. Never stop the tablets suddenly, because chest pain can worsen.

Clinical pearls

  • Shake Betoptic S well before each use, and put any other eye drops in at least 10 minutes before it.
  • With diabetes, betaxolol can hide the racing heartbeat that signals low blood sugar, so check your sugar when you feel off.
  • Tell your surgeon and anesthesia team you use betaxolol, including the eye drops, before any planned surgery.
  • Mention betaxolol to anyone prescribing verapamil, diltiazem, digoxin or amiodarone, since together they can slow or weaken the heart too much.
How you get itPrescription only
Comes asTablet, Eye drops
Earliest FDA record1985
Companies listing it with the FDA5
FDA label last updatedOct 31, 2019
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Betaxolol, written from its FDA label.

What Betaxolol is used for

▾

Betaxolol is used for different conditions depending on the product.

  • Betaxolol and Betaxolol Hydrochloride tablets: manage high blood pressure, alone or with other blood pressure medicines.
  • Betaxolol and Betaxolol Hydrochloride eye solutions: ocular hypertension and chronic open-angle glaucoma.
  • Betoptic S eye suspension 0.25%: elevated eye pressure in chronic open-angle glaucoma or ocular hypertension.

How Betaxolol works

▾

Betaxolol is a cardioselective beta-blocker. It mainly blocks beta-1 receptors, which are found mostly in the heart. It does not have significant membrane-stabilizing or intrinsic sympathomimetic activity.

By mouth, it lowers heart rate and cardiac output and reduces blood pressure. In the eye, it lowers pressure by reducing production of aqueous humor, the fluid inside the eye.

Betaxolol dosage

▾

Tablets are taken by mouth, usually once daily, alone or with a diuretic. Food does not affect how much is absorbed. Eye drops go into the affected eye(s), usually twice daily. Follow your prescriber and label for your exact regimen.

  • Tablets: full blood pressure effect usually appears within 7 to 14 days.
  • Tablets: a lower starting dose may be used in older adults and in severe kidney disease or dialysis.
  • Tablets: stop gradually over about 2 weeks.
  • Eye drops: pressure-lowering may take a few weeks to settle.
  • Betoptic S: shake well and wait 10 minutes after other eye medicines.

Dosing details from the FDA-approved label

From the Betaxolol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Hypertension (oral tablets)
    • Initial dose 10 mg once daily either alone or added to diuretic therapy
    • If the desired response is not achieved the dose can be doubled after 7 to 14 days
    • Maximum: Increasing the dose beyond 20 mg has not been shown to produce a statistically significant additional antihypertensive effect; the 40-mg dose has been studied and is well tolerated
    • Full antihypertensive effect usually seen within 7 to 14 days
  • Patients with renal failure (severe renal impairment and those undergoing dialysis)
    • Initial dose 5 mg once daily
    • If the desired response is not achieved, may be increased by 5 mg/day increments every 2 weeks
    • Maximum: 20 mg/day
    • Clearance of betaxolol declines with decreasing renal function
  • Patients with hepatic disease
    • Dosage adjustments are not routinely needed
    • Clearance is not significantly altered
  • Elderly patients
    • Consideration should be given to reduction in the starting dose to 5 mg
    • Especially prone to beta-blocker-induced bradycardia, which appears to be dose related
  • Cessation of oral therapy
    • If withdrawal is planned, achieve gradually over a period of about 2 weeks
    • Carefully observe patients and advise them to limit physical activity to a minimum
  • Ophthalmic solution (affected eye(s))
    • One to two drops in the affected eye(s) twice daily
    • IOP-lowering response may require a few weeks to stabilize; if not controlled, pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be added
  • Betoptic S ophthalmic suspension (affected eye(s))
    • One drop in the affected eye(s) twice daily
    • Shake well before using
    • May be used alone or with other IOP lowering medications
    • Administer other concomitant topical ophthalmic medications at least 10 minutes before instilling BETOPTIC S
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION: The initial dose of betaxolol tablets, USP in hypertension is ordinarily 10 mg once daily either alone or added to diuretic therapy. The full antihypertensive effect is usually seen within 7 to 14 days. If the desired response is not achieved the dose can be doubled after 7 to 14 days. Increasing the dose beyond 20 mg has not been shown to produce a statistically significant additional antihypertensive effect; but the 40-mg dose has been studied and is well tolerated. An increased effect (reduction) on heart rate should be anticipated with increasing dosage. If monotherapy with betaxolol tablets, USP does not produce the desired response, the addition of a diuretic agent or other antihypertensive should be considered (see PRECAUTIONS, Drug Interactions ). Dosage Adjustments For Specific Patients: Patients with renal failure: In patients with renal impairment, clearance of betaxolol declines with decreasing renal function. In patients with severe renal impairment and those undergoing dialysis, the initial dose of betaxolol tablets, USP is 5 mg once daily. If the desired response is not achieved, dosage may be increased by 5 mg/day increments every 2 weeks to a maximum dose of 20 mg/day. Patients with hepatic disease: Patients with hepatic disease do not have significantly altered clearance. Dosage adjustments are not routinely needed. Elderly patients: Consideration should be given to reduction in the starting dose to 5 mg in elderly patients. These patients are especially prone to beta-blocker-induced bradycardia, which appears to be dose related and sometimes responds to reductions in dose. Cessation of therapy: If withdrawal of betaxolol tablets, USP therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed and advised to limit physical activity to a minimum.

Read the full Dosage and Administration section on DailyMed →

Betaxolol side effects

▾

Most side effects are mild and temporary and are typical of beta-blockers.

Common side effects

  • Slow heart rate (bradycardia)
  • Tiredness or fatigue
  • Shortness of breath
  • Lethargy (low energy)
  • Dizziness
  • Headache
  • Impotence

When to get medical help

  • Get help right away for signs of heart failure, such as new shortness of breath or swelling. Your doctor may stop the medicine.
  • Call your doctor if you have wheezing, an asthma attack or trouble breathing.
  • Call your doctor if you have a very slow heartbeat, fainting or severe dizziness.
  • If you have coronary artery disease, do not stop the tablets suddenly. Chest pain (angina) can get worse, and heart attacks have been reported.
  • If you have diabetes, know that low blood sugar may be harder to notice, especially a fast heartbeat.
  • Tell your doctor about muscle weakness, double vision or drooping eyelids.
  • Call your doctor if Raynaud’s symptoms or signs of reduced blood flow to the brain start after beginning Betoptic S.

Betaxolol warnings and precautions

▾
  • Heart failure: beta-blockers can weaken heart pumping. Stop and call your doctor at the first signs.
  • Stopping suddenly: can worsen angina and has been followed by heart attack in people with coronary artery disease.
  • Lung disease: people with bronchospastic disease generally should not take beta-blockers. Asthma attacks have been reported.
  • Eye drops are absorbed: they can cause the same serious effects as the tablets.
  • Diabetes: low blood sugar signs may be masked, especially fast heartbeat.
  • Thyroid: signs of overactive thyroid may be hidden. Abrupt withdrawal might trigger thyroid storm.
  • Surgery: can raise anesthesia risks, so tell your surgical team.
  • Betoptic S: not for angle-closure glaucoma alone. Keep the bottle tip from touching anything to avoid contamination and bacterial keratitis (eye infection).

Betaxolol interactions

▾

Some medicines can add to betaxolol’s effects on heart rate and blood pressure.

  • Reserpine and similar drugs: low blood pressure or slow heartbeat.
  • Clonidine: stopping order matters.
  • Verapamil, diltiazem, nifedipine: low blood pressure, heart block or heart failure.
  • Digitalis, amiodarone, disopyramide: slow heart rate and conduction problems.
  • Heart-depressing anesthetics: extra care during surgery.
  • Other eye medicines with Betoptic S: apply them 10 minutes earlier.

Interactions listed in the FDA-approved label

From the Betaxolol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Cimetidine, nifedipine, chlorthalidone, hydrochlorothiazide: Coadministered with betaxolol and did not alter its pharmacokinetics.
  • Warfarin: Betaxolol has been shown not to potentiate the anticoagulant effect of warfarin.
  • Catecholamine-depleting drugs (eg, reserpine): May have an additive effect when given with beta-blocking agents. Closely observe for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.
  • Clonidine: Stopping therapy in patients receiving a beta-blocker and clonidine concurrently is addressed in the label. Discontinue the beta-blocker slowly over several days before the gradual withdrawal of clonidine.
  • Oral calcium antagonists (dihydropyridines such as nifedipine; verapamil; diltiazem): Hypotension, AV conduction disturbances, and left ventricular failure have been reported; hypotension more likely with dihydropyridines, left ventricular failure and AV conduction disturbances including complete heart block more likely with verapamil or diltiazem. May be used with beta-blockers when heart function is normal, but should be avoided in patients with impaired cardiac function.
  • Digitalis glycosides: Both slow atrioventricular conduction and decrease heart rate; concomitant use can increase the risk of bradycardia.
  • Amiodarone: Antiarrhythmic with negative chronotropic properties that may be additive to those seen with beta blockers.
  • Disopyramide: Associated with severe bradycardia, asystole and heart failure when administered with beta blockers.
  • Anesthetic agents that depress the myocardium (ether, cyclopropane, trichloroethylene): These agents depress the myocardium. Particular care should be taken (see Warnings, Major surgery).
Read the label’s full interactions text

Drug Interactions The following drugs have been coadministered with betaxolol and have not altered its pharmacokinetics: cimetidine, nifedipine, chlorthalidone, and hydrochlorothiazide. Concomitant administration of betaxolol with the oral anticoagulant warfarin has been shown not to potentiate the anticoagulant effect of warfarin. Catecholamine-depleting drugs (eg, reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with a beta-adrenergic receptor blocking agent plus a catecholamine depletor should therefore be closely observed for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. Should it be decided to discontinue therapy in patients receiving beta-blockers and clonidine concurrently, the beta-blocker should be discontinued slowly over several days before the gradual withdrawal of clonidine. Literature reports suggest that oral calcium antagonists may be used in combination with beta-adrenergic blocking agents when heart function is normal, but should be avoided in patients with impaired cardiac function. Hypotension, AV conduction disturbances, and left ventricular failure have been reported in some patients receiving beta-adrenergic blocking agents when an oral calcium antagonist was added to the treatment regimen. Hypotension was more likely to occur if the calcium antagonist were a dihydropyridine derivative, eg, nifedipine, while left ventricular failure and AV conduction disturbances, including complete heart block, were more likely to occur with either verapamil or diltiazem. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers. Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Betaxolol

▾
  • Betoptic S should not be used with sinus bradycardia, second- or third-degree AV block, overt heart failure, cardiogenic shock, or allergy to any component.
  • Tell your doctor about asthma or lung disease, heart problems, diabetes, thyroid disease, muscle weakness, or poor circulation.
  • Tablets should not be given with untreated pheochromocytoma.
  • Kidney disease, dialysis, and older age may call for a lower starting dose of the tablets. Liver disease usually needs no routine change.
  • Pregnancy: Betoptic S only if benefit justifies risk.
  • Breastfeeding: discuss with your doctor.
  • Betoptic S has been studied in children for eye pressure.

Betaxolol overdose

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Too much betaxolol by mouth may cause a slow heart rate, heart failure, low blood pressure, bronchospasm or low blood sugar. Treatment is stopped and the person is observed closely. Get emergency help right away.

What Betaxolol does in the body

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Betaxolol tablets reduce heart rate, cardiac output and blood pressure at rest and during exercise. As eye drops, the effect begins within about 30 minutes and peaks around 2 hours. One dose lowers eye pressure for about 12 hours. Studies found no significant effect on breathing tests in nine people with reactive airway disease after eye drops.

How your body processes Betaxolol

▾

Oral betaxolol is absorbed completely, with about 89% reaching the bloodstream, and food or alcohol does not change this. Blood levels peak about 3 hours after a dose. The half-life is about 14 to 22 hours, so once-daily dosing works. It is cleared mainly by the liver, then the kidneys. Kidney impairment and dialysis raise drug levels, and older adults may clear it more slowly.

How to store Betaxolol

▾

Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) . Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

143

Supplements & herbs that interact with Betaxolol

143 supplements and herbal products have documented interactions with Betaxolol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 118
  • Minor · 20
Every supplement checked against Betaxolol — ranked by severity The full interaction hub: 5 major · 118 moderate · 20 minor · every one linked to its full report. Check Betaxolol against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Betaxolol has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Betaxolol nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Betaxolol: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Betaxolol — the kind of thing our pharmacy team would talk through with you at the counter.

What is betaxolol for?

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It depends on the form. The tablets treat high blood pressure. The eye drops lower pressure in the eye for ocular hypertension and chronic open-angle glaucoma.

How do I take it?

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Tablets are taken by mouth, usually once a day, and food does not change absorption. Eye drops go into the affected eye(s), usually twice a day. Betoptic S needs a good shake first. Follow your prescriber’s directions.

Can I stop the tablets if I feel fine?

▾
Please don’t stop on your own. Stopping suddenly can make chest pain worse and has been linked to heart attacks. If you need to stop, your doctor will taper you off over about 2 weeks.

What side effects should I expect?

▾
Most are mild, like a slow heartbeat, tiredness, dizziness, headache or shortness of breath. Call your doctor for wheezing, swelling, fainting or worsening breathlessness.

Do the eye drops affect the rest of my body?

▾
They can. Some of the drug is absorbed, so heart and breathing effects are possible. Tell us about asthma, heart or diabetes history, and report any breathing trouble.

I wear contacts. Is that a problem with Betoptic S?

▾
Take your lenses out before putting in Betoptic S. You can put them back in 15 minutes later. The preservative can be absorbed by soft lenses. If you use other eye drops, use them at least 10 minutes before Betoptic S.

Is Betaxolol available over the counter?

▾
No. Betaxolol is a prescription medicine: every Betaxolol product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Betaxolol first available?

▾
The earliest FDA record we hold for Betaxolol is from 1985: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Betaxolol was first used.

Who makes Betaxolol?

▾
5 companies currently list Betaxolol products in the FDA's NDC Directory, including Epic Pharma LLC, Kvk-tech, Inc., PuraCap Laboratories LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Betaxolol on HelloPharmacist

Detailed data & references for Betaxolol Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Betaxolol forms and strengths (how it comes)

Betaxolol is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Betaxolol inactive ingredients by manufacturer.

Tablet

By mouth
How this form is used
What it may be used for
  • Betaxolol and Betaxolol Hydrochloride tablets are used to manage high blood pressure.
  • They may be used alone or with other blood pressure medicines, especially thiazide-type diuretics.
Important instructions
  • Betaxolol tablets are taken by mouth, usually once daily.
  • The full blood pressure effect is usually seen within 7 to 14 days.
  • Betaxolol tablets should be stopped gradually over about 2 weeks if your doctor plans to stop them.
Available strengths 2 strengths
10 FDA-listed product records ⓘ

Eye drops

In the eye
Brands Betoptic S
How this form is used
What it may be used for
  • Betaxolol and Betaxolol Hydrochloride ophthalmic solutions are used for ocular hypertension and chronic open-angle glaucoma.
  • Betoptic S is used for elevated eye pressure in chronic open-angle glaucoma or ocular hypertension.
  • Betaxolol ophthalmic solutions may be used alone or with other anti-glaucoma drugs.
Important instructions
  • Betaxolol and Betaxolol Hydrochloride ophthalmic solutions are placed in the affected eye(s) twice daily.
  • Betoptic S is placed in the affected eye(s) twice daily and should be shaken well before use.
  • Betoptic S: use other eye medicines at least 10 minutes before it.
  • Betoptic S: remove contact lenses first and wait 15 minutes before putting them back in.
Available strengths 2 strengths
5 FDA-listed product records ⓘ

Betaxolol on the U.S. market: products, makers and brands

How Betaxolol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

5 companies list 8 Betaxolol product records with the FDA, mostly as tablet, eye drops; the earliest marketing or approval year on record is 1985. Brand names on the directory include Kerlone, Betoptic S; the rest are generics.

2
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
3
Brand names
8
FDA-listed product records ⓘ
1985
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Epic Pharma LLC25%
Kvk-tech, Inc.25%
PuraCap Laboratories LLC25%
Novartis Pharmaceuticals Corporation13%
Sandoz Inc13%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Betaxolol is used (Medicaid data)

A general measure of how commonly Betaxolol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Betaxolol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,493
Medicaid prescriptions filled (Q1–Q4 2025)
$197,239 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Betaxolol prescribed? Of the 1,601 medications we measure, Betaxolol ranks #1,229 by Medicaid prescriptions — more than 23% of them.

Where Betaxolol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Betaxolol product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg/mL ophthalmic solution is the most-dispensed Betaxolol product — about 49% of these Medicaid prescriptions.

betaxolol 5 MG/ML Ophthalmic Solution Most dispensed

737 Medicaid prescriptions (Q1–Q4 2025) 49% of Betaxolol prescriptions shown $57,733 gross reimbursement (before rebates) ≈ $78 per prescription (gross)

Summed across the 3 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308720

betaxolol hydrochloride 10 MG Oral Tablet

458 Medicaid prescriptions (Q1–Q4 2025) 31% of Betaxolol prescriptions shown $15,923 gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1297753

betaxolol 2.5 MG/ML Ophthalmic Suspension

287 Medicaid prescriptions (Q1–Q4 2025) 19% of Betaxolol prescriptions shown $123,053 gross reimbursement (before rebates) ≈ $429 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308719

betaxolol hydrochloride 20 MG Oral Tablet

11 Medicaid prescriptions (Q1–Q4 2025) <1% of Betaxolol prescriptions shown $529 gross reimbursement (before rebates) ≈ $48 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1297757

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Betaxolol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 16 listed Betaxolol NDCs with Medicaid activity.

Compare Betaxolol products

A representative set of FDA-listed product records for Betaxolol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Eye drops
2.8 mg/mL Ophthalmic Novartis Pharmaceuticals Corporation NDA View NDC →
5.6 mg/mL Ophthalmic Sandoz Inc NDA AUTHORIZED GENERIC View NDC →
💊Tablet
10 mg Oral Epic Pharma LLC ANDA View NDC →
20 mg Oral Epic Pharma LLC ANDA View NDC →
10 mg Oral Kvk-tech, Inc. ANDA View NDC →
20 mg Oral Kvk-tech, Inc. ANDA View NDC →
10 mg Oral PuraCap Laboratories LLC ANDA View NDC →
20 mg Oral PuraCap Laboratories LLC ANDA View NDC →

Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Betaxolol NDCs →

Betaxolol recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Betaxolol recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class I Sep 20, 2023 · Terminated · KVK-Tech, Inc.
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
  • Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01. Lots: Lot # 17853A, Exp. 06/30/2027 FDA record D-0049-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Betaxolol RxCUI 1520 3 dose forms · 4 strengths
  1. Dose form (SCDF) Ophthalmic Solution RxCUI 377437 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 308720
  2. Dose form (SCDF) Ophthalmic Suspension RxCUI 379140 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG/ML RxCUI 308719

Look up RxCUI 1520 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Betaxolol costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 10 mg $0.583 per tablet NDC details & price history
Tablet, Coated · Oral 10 mg $0.591 per tablet NDC details & price history
Tablet, Coated · Oral 20 mg $0.795 per tablet NDC details & price history
Suspension/ Drops · Ophthalmic 2.8 mg/mL $42.62–$42.88 per mL NDC details & price history
Solution/ Drops · Ophthalmic 5.6 mg/mL $8.96–$8.99 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Betaxolol brand names

Betaxolol is sold under 2 brand names in the FDA directory — Kerlone, Betoptic S. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Kerlone Betoptic S

Who makes Betaxolol: manufacturers and labelers

5 companies list Betaxolol products with the FDA. By number of product records, the largest are Epic Pharma LLC, Kvk-tech, Inc., PuraCap Laboratories LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Epic Pharma LLC 2 Kvk-tech, Inc. 2 PuraCap Laboratories LLC 2 Novartis Pharmaceuticals Corporation 1 Sandoz Inc 1

Betaxolol drug class (RxNorm)

Betaxolol belongs to the beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, selective, Beta blocking agents
How it works Adrenergic beta-Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Betaxolol page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 31, 2019
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Betaxolol.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Betaxolol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
Finished products in the current FDA directory
8
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
PuraCap Laboratories LLC
Linked label effective
Oct 31, 2019
Composite sections available
14
Linked SPL Set ID
e198244d-fda3-4015-8c01-390f3f88e238
Linked SPL Document ID
7ee988e7-153d-4d55-b4ec-1a8da8f78f1d
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. PuraCap Laboratories LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →