Prescription medicine
Bepotastine Brand names: Bepreve
Bepotastine (Bepreve) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $9.39 per mL (Bepotastine 1.5% eye drop) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the bepotastine FDA label on DailyMed (effective August 20, 2024, Bausch & Lomb Americas Inc.); the NDA 22288 record on Drugs@FDA; every bepotastine label on DailyMed.
Highlights of the record
FDA label of August 20, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
Forms and strengths
- 15 mg/ml
Solution/ drops; solution.
On the market
- Earliest approval on file
- September 8, 2009 Bepreve, Bausch And Lomb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first March 5, 2019; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 4 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $9.39 per mL Bepotastine 1.5% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 641 through July 30, 2026
What is bepotastine used for?
From the label: indications and usageBepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine Besilate Ophthalmic Solution is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
FDA pharmacologic class: Histamine-1 Receptor Antagonist.
Source: FDA drug label (Bepotastine Besilate), Bausch & Lomb Americas Inc., effective August 20, 2024 (SPL set 70430ab5-cd0a-451e-acab-347a2f981898), via openFDA; the full label on DailyMed
Is there a generic for bepotastine (Bepreve)?
The FDA approved the first generic bepotastine on March 5, 2019. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists bepotastine from 4 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.
- 2009 earliest approval on file
- 2019 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bepotastine (Bepreve)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.39 per mL (Bepotastine 1.5% eye drop), down 36% from $14.63 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.
- Bepotastine 1.5% eye drop (generic)
- Bepreve 1.5% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bepotastine 1.5% eye drop | Generic | $9.39 per mL | n/a | -36% |
| Bepreve 1.5% eye drops | Brand | $55.94 per mL | n/a | +2% |
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 bepotastine label say about other medicines?
The bepotastine label names 1 other medicine 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 |
|---|---|---|
| Benzalkonium | warnings and precautions | Patient should remove contact lenses prior to instillation of Bepotastine Besilate Ophthalmic Solution, because benzalkonium chloride may be absorbed by soft contact lenses. |
Source: FDA drug label (Bepotastine Besilate), Bausch & Lomb Americas Inc., effective August 20, 2024 (SPL set 70430ab5-cd0a-451e-acab-347a2f981898), via openFDA; the full label on DailyMed
What do FAERS reports show for bepotastine?
The FDA Adverse Event Reporting System holds 641 reports that list bepotastine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 38 are coded as a death and 173 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 next?
- Other antihistamines
- the pharmacologic class, with prices and generics
- Bepotastine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other