Active ingredient
Bepotastine
8 finished FDA listings contain Bepotastine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BEPOTASTINE BESILATE, BEPOTASTINE BESYLATE
- Dosage forms
- Solution, Solution/ Drops
- Routes
- Ophthalmic
- Manufacturers / labelers
- 6
- Strengths listed
- 15 mg/ml
- Brand names in FDA listings
- Bepreve
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 863035
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022288 | BAUSCH AND LOMB INC | 2009-09-08 | 3 |
| ANDA 206220 | MYLAN | 2019-03-18 | 1 |
| ANDA 214588 | ALEMBIC | 2023-04-05 | 2 |
| ANDA 217770 | SOMERSET THERAPS LLC | 2024-08-14 | 2 |
Official labeling on DailyMed
- BEPOTASTINE BESILATE SOLUTION/ DROPS [MYLAN PHARMACEUTICALS INC.] · version 4 · 2025-11-17
- BEPOTASTINE BESILATE SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 4 · 2024-10-14
- BEPOTASTINE BESILATE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.] · version 4 · 2024-08-22
- BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] · version 4 · 2023-07-24
- BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2023-07-24
- BEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] · version 14 · 2022-10-24
- BEPOTASTINE BESILATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] · version 1 · 2021-05-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.