FDA.reportPublic FDA data

bepotastine besilate 1.5 % Ophthalmic Solution

RxCUI
863038
RxNorm name
bepotastine besilate 1.5 % Ophthalmic Solution
Display name
bepotastine besilate 1.5 % Ophthalmic Solution
Full name
bepotastine besilate 1.5 % Ophthalmic Solution
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bepotastine BesilateBEPOTASTINE BESILATESomerset Therapeutics, LLCcd6a061d-8ad7-4ad1-b039-1e3aa3435d322024-10-10Warnings, Adverse reactionsExact identifier
rxcui: 863038
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Americas Inc.70430ab5-cd0a-451e-acab-347a2f9818982024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 863038
Bepotastine Besilate Ophthalmic Solution 1.5%BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5%Alembic Pharmaceuticals Inc.f68306a9-80ec-4bc5-8c00-1e1328f21e362023-07-21Warnings, Adverse reactionsExact identifier
rxcui: 863038
Bepotastine Besilate Ophthalmic Solution 1.5%BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5%Alembic Pharmaceuticals Limitedde111d74-c740-47b3-adc7-4b855df2c5612023-07-21Warnings, Adverse reactionsExact identifier
rxcui: 863038
BepreveBEPOTASTINE BESILATEBausch & Lomb Incorporated68bbf6a0-c4b5-47c1-8a1c-08220fbdbce62022-08-31Warnings, Adverse reactionsExact identifier
rxcui: 863038
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Incorporated995f4fe0-d861-4137-8090-a8ffc71c46f42020-12-31Warnings, Adverse reactionsExact identifier
rxcui: 863038
Bepotastine BesilateBEPOTASTINE BESILATEMylan Pharmaceuticals Inc.75178670-aa57-45f9-94d5-efcf8305e6832018-03-20Warnings, Adverse reactionsExact identifier
rxcui: 863038

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]314These highlights do not include all the information needed to use BEPREVE safely and effectively. See full prescribing information for BEPREVE. BEPREVE ® (bepotastine besilate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 200920220831
cd6a061d-8ad7-4ad1-b039-1e3aa3435d32bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]34These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION BEPOTASTINE BESILATE ophthalmic solution 1.5%, for topical ophthalmic use Initial U.S. Approval:200920241010
70430ab5-cd0a-451e-acab-347a2f981898bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]34These highlights do not include all the information needed to use Bepotastine Besilate Ophthalmic Solution safely and effectively. See full prescribing information for Bepotastine Besilate Ophthalmic Solution. Bepotastine Besilate Ophthalmic Solution, for topical ophthalmic use Initial U.S. Approval: 200920240820
f68306a9-80ec-4bc5-8c00-1e1328f21e36bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]34These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION. BEPOTASTINE Besilate Ophthalmic Solution 1.5% for topical ophthalmic use Initial U.S. Approval: 200920230721
75178670-aa57-45f9-94d5-efcf8305e683bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]34These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION. BEPOTASTINE BESILATE ophthalmic solution, for topical application in the eye Initial U.S. Approval: 200920180320
de111d74-c740-47b3-adc7-4b855df2c561bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]31These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION. BEPOTASTINE Besilate Ophthalmic Solution 1.5% for topical ophthalmic use Initial U.S. Approval: 200920230721
995f4fe0-d861-4137-8090-a8ffc71c46f4bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]31These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION. BEPOTASTINE BESILATE OPHTHALMIC SOLUTION, 1.5%, for topical ophthalmic use Initial U.S. Approval: 200920201231
7c77517f-24c7-4778-94a7-873d11c3c657bepotastine besilate 1.5 % Ophthalmic Solution [PSN] · bepotastine besilate 15 MG/ML Ophthalmic Solution [SCD] · bepotastine besilate 1.5 % Ophthalmic Solution [SY]31These highlights do not include all the information needed to use BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% safely and effectively. See full prescribing information for BEPREVE™. BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% Initial U.S. Approval: 200920090801