FDA.reportPublic FDA data

Bepotastine Besilate

Product NDC
82260-630
11-digit product format
822600630
Labeler code
82260
Product ID
82260-630_202287f2-01bc-1d43-e063-6294a90a8da1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bepotastine besilate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA022288
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-05-28
Substance
BEPOTASTINE BESYLATE
Active strength
15 mg/mL
Pharmacologic classes
Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022288-001BEPREVEBEPOTASTINE BESILATE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N022288-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022288-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Americas Inc.70430ab5-cd0a-451e-acab-347a2f9818982024-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 022288
application number: NDA022288
ndc (product): 82260-630
BepreveBEPOTASTINE BESILATEBausch & Lomb Incorporated68bbf6a0-c4b5-47c1-8a1c-08220fbdbce62022-08-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 022288
application number: NDA022288
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Incorporated995f4fe0-d861-4137-8090-a8ffc71c46f42020-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 022288
application number: NDA022288

Additional Listing Data#

Finished product
Yes
Brand name base
Bepotastine Besilate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEPOTASTINE BESYLATE15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6W18MO1QR3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863038Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70430ab5-cd0a-451e-acab-347a2f981898Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79844758-4d97-abf0-31a3-9b38208d65a7Product name420250317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82260-630-05Bepotastine Besilate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54
82260-630-05Bepotastine Besilate1 in 1 CARTONSOLUTION/ DROPS14
82260-630-10Bepotastine Besilate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS104
82260-630-10Bepotastine Besilate1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-630-05ML - Milliliter82260-630ad091038-3063-459f-90f8-62381f2a797012024-06-10
82260-630-10ML - Milliliter82260-630ff2584cb-7304-4e66-8149-6042d1c649d212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-630BEPOTASTINE BESILATE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.]4Current NDC, Legacy NDC, 4 package rows20240822_70430ab5-cd0a-451e-acab-347a2f981898.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863038bepotastine besilate 1.5 % Ophthalmic SolutionPSN70430ab5-cd0a-451e-acab-347a2f9818984
863038bepotastine besilate 15 MG/ML Ophthalmic SolutionSCD70430ab5-cd0a-451e-acab-347a2f9818984
863038bepotastine besilate 1.5 % Ophthalmic SolutionSY70430ab5-cd0a-451e-acab-347a2f9818984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82260-630-05822600630051 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER2021-05-280000-00-00NoNoCurrent
82260-630-10822600630101 BOTTLE, DROPPER in 1 CARTON (82260-630-10) / 10 mL in 1 BOTTLE, DROPPER2021-05-280000-00-00NoNoCurrent