Quick answers
- What is Bepotastine used for?
- The FDA-approved label (Bepreve, Bausch & Lomb Incorporated, August 31, 2022) says: “BEPREVE ® (bepotastine 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. BEPREVE is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bepotastine have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bepotastine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bepotastine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bepotastine?
- 6 companies list prescription products of Bepotastine in the FDA NDC Directory, including Somerset Therapeutics, LLC, Bausch & Lomb Incorporated and Alembic Pharmaceuticals Inc..
What Bepotastine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BEPREVE ® (bepotastine 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. BEPREVE is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
— FDA label: Bepreve, Bausch & Lomb Incorporated, effective August 31, 2022. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · Solution |
|---|---|
| Route | Ophthalmic |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Bepreve |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| bepotastine besilate 15 mg/mL solution | Generic | $8.19–$9.83 per mL 2 packages, lowest to highest |
| bepotastine besilate 15 mg/mL solution/ drops | Generic | $8.19–$9.83 per mL 6 packages, lowest to highest |
| bepotastine besylate 15 mg/mL solution/ drops | Generic | $8.19–$9.83 per mL 2 packages, lowest to highest |
| bepotastine besylate 15 mg/mL solution/ drops | Brand: Bepreve | $55.94 per mL |
NADAC list of November 4, 2026; these prices took effect between March 18, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Somerset Therapeutics, LLC2 products
- Bausch & Lomb Incorporated2 products
- Alembic Pharmaceuticals Inc.1 product
- Alembic Pharmaceuticals Limited1 product
- Mylan Pharmaceuticals Inc.1 product
- Bausch & Lomb Americas Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022288 BEPREVE | Bausch and Lomb Inc | September 8, 2009 | 3, latest February 9, 2018 2018: Labeling · 2016: Manufacturing (CMC) · 2012: Labeling |
Generic approvals (3)
- ANDA206220Mylan · March 18, 2019
- ANDA214588Alembic · April 5, 2023
- ANDA217770Somerset Theraps LLC · August 14, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 863038, 863042 |
|---|---|
| SPL set ID of the quoted label | 68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6 |
| FDA labels (SPL) | 7 |
| FDA applications | NDA022288, 3 ANDA |
| Active ingredients (FDA) | BEPOTASTINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bepreve, Bausch & Lomb Incorporated, effective August 31, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →