Prescription medicine
Levobunolol First approved as Betagan
Levobunolol (Betagan) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $2.82 per mL (Levobunolol 0.5% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the levobunolol FDA label on DailyMed (effective July 24, 2024, Bausch & Lomb Incorporated); the NDA 19219 record on Drugs@FDA; every levobunolol label on DailyMed.
Highlights of the record
FDA label of July 24, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLevobunolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.
Forms and strengths
- 5 mg/ml
Solution/ drops.
On the market
- Earliest approval on file
- December 19, 1985 Betagan, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first March 4, 1994; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.82 per mL Levobunolol 0.5% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 99 through July 30, 2026
What is levobunolol used for?
From the label: indications and usageLevobunolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.
Conditions named in the indications of levobunolol's FDA labels, with every medicine labeled for each:
From other levobunolol labelsGlaucoma: INDICATIONS AND USAGE Levobunolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.
FDA pharmacologic class: beta-Adrenergic Blocker.
Source: FDA drug label (Levobunolol Hydrochloride), Bausch & Lomb Incorporated, effective July 24, 2024 (SPL set 5ab1efbe-530b-4787-b40a-c7dbf18161e1), via openFDA; the full label on DailyMed
Is there a generic for levobunolol (Betagan)?
The FDA approved the first generic levobunolol on March 4, 1994. 8 generic applications are approved; 1 of them carries 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 levobunolol from 1 labeler under a generic (ANDA) application. 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
- 1994 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levobunolol (Betagan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.82 per mL (Levobunolol 0.5% eye drops), up 50% from $1.87 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Levobunolol 0.5% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Levobunolol 0.5% eye drops | Generic | $2.82 per mL | n/a | +50% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the levobunolol label say about other medicines?
The levobunolol label names 2 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 |
|---|---|---|
| Dobutamine | warnings | If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol (see OVERDOSAGE ). |
| Isoproterenol | warnings | If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol (see OVERDOSAGE ). |
Source: FDA drug label (Levobunolol Hydrochloride), Bausch & Lomb Incorporated, effective July 24, 2024 (SPL set 5ab1efbe-530b-4787-b40a-c7dbf18161e1), via openFDA; the full label on DailyMed
What do FAERS reports show for levobunolol?
The FDA Adverse Event Reporting System holds 99 reports that list levobunolol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 18 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.
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 levobunolol?
18 other medicines are given the same way (ophthalmic) and in the same FDA class as levobunolol or labeled mainly for the same use (glaucoma), the same class first. Glaucoma lists all 20 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 (ophthalmic) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Timolol | Glaucoma | 21 labelers | $0.774 per mL 0.5% eye drops | No current entry |
| Dorzolamide and timolol | Glaucoma | 14 labelers | $0.893 per mL Dorzolamide-timolol eye drops | No current entry |
| Brimonidine and timolol | Glaucoma | 14 labelers | $2.15 per mL 0.2%-0.5% | No current entry |
| Betaxolol | Glaucoma | none listed | $8.97 per mL 0.5% eye drop | No current entry |
| Carteolol | Glaucoma | 1 labeler | $1.63 per mL 1% eye drops | No current entry |
| Brimonidine | Glaucoma | 12 labelers | $9.06 per mL 0.1% drop | No current entry |
| Bimatoprost | Glaucoma | 13 labelers | $6.97 per mL 0.03% eye drops | No current entry |
| Latanoprost | Glaucoma | 14 labelers | $1.58 per mL 0.005% eye drops | No current entry |
Every medicine labeled for the same conditions as levobunolol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to levobunolol
- 18 medicines for the same use
- Other beta blockers
- the pharmacologic class, with prices and generics
- Levobunolol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other