Drug
Who makes bepotastine besilate?
4 companies list bepotastine besilate as a human prescription drug, including under the names Bepreve. Forms: solution; solution/ drops. Routes: ophthalmic.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing bepotastine besilate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bausch & Lomb Ireland LimitedUnited States | solution/ drops | NDA, NDA AUTHORIZED GENERICNDA022288 | 2 | 4 |
| Somerset Therapeutics Private LimitedIndia | solution | ANDAANDA217770 | 2 | 1 |
| Bausch & Lomb Americas Inc. | solution/ drops | NDA AUTHORIZED GENERICNDA022288 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | solution/ drops | ANDAANDA206220 | 1 | 0 |
Bulk ingredient listings
- ICROM SRLItaly · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Micro Labs LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes bepotastine besilate?
- 4 companies list bepotastine besilate as a human prescription drug in the openFDA NDC Directory, led by Bausch & Lomb Ireland Limited, Somerset Therapeutics Private Limited, Bausch & Lomb Americas Inc., Mylan Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Bepreve?
- 2 companies list bepotastine besilate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies bepotastine besilate active ingredient?
- 3 companies list bepotastine besilate as a bulk ingredient, including ICROM SRL, MSN Laboratories Private Limited,, Micro Labs Limited.