FDA.reportPublic FDA data

Bepotastine Besilate Ophthalmic Solution 1.5%

Product NDC
62332-598
11-digit product format
623320598
Labeler code
62332
Product ID
62332-598_ce72ab26-85a1-4fb5-a605-80bebe22f929
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bepotastine Besilate Ophthalmic Solution 1.5%
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214588
Marketing category
ANDA
Marketing start
2023-04-05
Substance
BEPOTASTINE BESILATE
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
A214588-001BEPOTASTINE BESILATEBEPOTASTINE BESILATE1.5%SOLUTION/DROPS / OPHTHALMICAT2023-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214588-001AT

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 22:54:322026-06A214588-001BEPOTASTINE BESILATE1.5%SOLUTION/DROPS / OPHTHALMICAT2023-04-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214588-001AT1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application applno (ANDA): 214588
application number: ANDA214588
ndc (product): 62332-598
Bepotastine Besilate Ophthalmic Solution 1.5%BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5%Alembic Pharmaceuticals Limitedde111d74-c740-47b3-adc7-4b855df2c5612023-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214588
application number: ANDA214588

Additional Listing Data#

Finished product
Yes
Brand name base
Bepotastine Besilate Ophthalmic Solution 1.5%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEPOTASTINE BESILATE15 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
f68306a9-80ec-4bc5-8c00-1e1328f21e36Available 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
62332-598-05Bepotastine Besilate Ophthalmic Solution 1.5%1 in 1 CARTONSOLUTION/ DROPS14
62332-598-05Bepotastine Besilate Ophthalmic Solution 1.5%05 mL in 1 BOTTLESOLUTION/ DROPS054
62332-598-10Bepotastine Besilate Ophthalmic Solution 1.5%10 mL in 1 BOTTLESOLUTION/ DROPS104
62332-598-10Bepotastine Besilate Ophthalmic Solution 1.5%1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-598-05ML - Milliliter62332-59804aa01d3-f5ac-4d90-9428-d656efbd03c212023-10-16
62332-598-10ML - Milliliter62332-5982b7bc526-c858-4c7f-9e8d-b4993df10bae12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-598BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, 4 package rows20230722_f68306a9-80ec-4bc5-8c00-1e1328f21e36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863038bepotastine besilate 1.5 % Ophthalmic SolutionPSNf68306a9-80ec-4bc5-8c00-1e1328f21e364
863038bepotastine besilate 15 MG/ML Ophthalmic SolutionSCDf68306a9-80ec-4bc5-8c00-1e1328f21e364
863038bepotastine besilate 1.5 % Ophthalmic SolutionSYf68306a9-80ec-4bc5-8c00-1e1328f21e364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-598-05623320598051 BOTTLE in 1 CARTON (62332-598-05) / 5 mL in 1 BOTTLE1 bottle2023-07-18NoNoCurrent
62332-598-10623320598101 BOTTLE in 1 CARTON (62332-598-10) / 10 mL in 1 BOTTLE1 bottle2023-04-05NoNoCurrent