Prescription medicine
Betaxolol Brand names: Betoptic
Betaxolol (Betoptic) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.591 per betaxolol 10 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $42.75 per mL (Betoptic s 0.25% eye drop).
- Generic listed
Check it at the source: the betaxolol FDA label on DailyMed (effective December 20, 2023, Epic Pharma LLC); the NDA 19270 record on Drugs@FDA; every betaxolol label on DailyMed.
Highlights of the record
FDA label of December 20, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBetaxolol is indicated in the management of hypertension.
Forms and strengths
- 10 mg
- 20 mg
- 2.8 mg/ml
- 5.6 mg/ml
Film-coated tablet; coated tablet; suspension/ drops; solution/ drops.
On the market
- Earliest approval on file
- August 30, 1985 Betoptic, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first October 22, 1999; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.591 per tablet Betaxolol 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2021 1 Class I among all firms' recalls; latest September 20, 2023
- FAERS reports
- 1,304 through July 30, 2026
What is betaxolol used for?
From the label: indications and usageBetaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.
Conditions named in the indications of betaxolol's FDA labels, with every medicine labeled for each:
From other betaxolol labelsHigh blood pressure: INDICATIONS AND USAGE Betaxolol is indicated in the management of hypertension.
Glaucoma: BETOPTIC S ® (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.
FDA pharmacologic class: beta-Adrenergic Blocker.
Source: FDA drug label (Betaxolol), Epic Pharma LLC, effective December 20, 2023 (SPL set bf716efe-0a9f-43b1-9d8a-c69330b82e18), via openFDA; the full label on DailyMed
Is there a generic for betaxolol (Betoptic)?
The FDA approved the first generic betaxolol on October 22, 1999. 6 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists betaxolol from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1985 earliest approval on file
- 1999 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for betaxolol (Betoptic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.591 per Betaxolol 10 mg tablet, down 5% from $0.624 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Betaxolol 10 mg tablet (generic)
- Betoptic s 0.25% eye drop (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Betaxolol 10 mg tablet | Generic | $0.591 per tablet | $17.74 | -5% |
| Betaxolol 20 mg tablet | Generic | $0.795 per tablet | $23.85 | -4% |
| Betaxolol HCl 0.5% eye drop | Generic | $8.97 per mL | n/a | +0.1% |
| Betoptic s 0.25% eye drop | Brand | $42.75 per mL | n/a | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has betaxolol been recalled?
The FDA's Enforcement Report lists 3 recalls naming betaxolol since 2021: 1 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 20, 2023 | Class I | KVK-Tech, Inc. | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. |
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
| October 4, 2021 | Class II | Akorn, Inc. | Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the betaxolol label say about other medicines?
The betaxolol label names 12 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers. |
| Benzalkonium | warnings and precautions | The preservative in BETOPTIC S, benzalkonium chloride, may be absorbed by soft contact lenses. |
| Chlorthalidone | drug interactions | Drug Interactions The following drugs have been coadministered with betaxolol and have not altered its pharmacokinetics: cimetidine, nifedipine, chlorthalidone, and hydrochlorothiazide. |
| Cimetidine | drug interactions | Drug Interactions The following drugs have been coadministered with betaxolol and have not altered its pharmacokinetics: cimetidine, nifedipine, chlorthalidone, and hydrochlorothiazide. |
| Clonidine | drug interactions | 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. |
| Diltiazem | drug interactions | 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. |
| Disopyramide | drug interactions | Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers. |
| Epinephrine | warnings and precautions | Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions. |
| Hydrochlorothiazide | drug interactions | Drug Interactions The following drugs have been coadministered with betaxolol and have not altered its pharmacokinetics: cimetidine, nifedipine, chlorthalidone, and hydrochlorothiazide. |
| Nifedipine | drug interactions | 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. |
| Verapamil | drug interactions | 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. |
| Warfarin | drug interactions | Concomitant administration of betaxolol with the oral anticoagulant warfarin has been shown not to potentiate the anticoagulant effect of warfarin. |
Source: FDA drug label (Betaxolol), Epic Pharma LLC, effective December 20, 2023 (SPL set bf716efe-0a9f-43b1-9d8a-c69330b82e18), via openFDA; the full label on DailyMed
What do FAERS reports show for betaxolol?
The FDA Adverse Event Reporting System holds 1,304 reports that list betaxolol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 138 are coded as a death and 672 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as betaxolol?
75 other medicines are given the same way (oral) and in the same FDA class as betaxolol or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metoprolol | High blood pressure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Carvedilol | High blood pressure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Atenolol | High blood pressure | 35 labelers | $0.0217 per tablet 25 mg tablet | No current entry |
| Labetalol | High blood pressure | 31 labelers | $0.215 per tablet 300 mg tablet | No current entry |
| Nebivolol | High blood pressure | 23 labelers | $0.141 per tablet 10 mg tablet | A presentation being discontinued |
| Nadolol | High blood pressure | 16 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Bisoprolol | High blood pressure | 24 labelers | $0.114 per tablet 5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to betaxolol
- 75 medicines for the same use
- Other beta blockers
- the pharmacologic class, with prices and generics
- Betaxolol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other