FDA.reportPublic FDA data

Bepreve

Product NDC
24208-629
11-digit product format
242080629
Labeler code
24208
Product ID
24208-629_a4c88d72-eb17-446a-9da5-6bcf1263377f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bepotastine besilate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA022288
Marketing category
NDA
Marketing start
2009-09-08
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
BepreveBEPOTASTINE BESILATEBausch & Lomb Incorporated68bbf6a0-c4b5-47c1-8a1c-08220fbdbce62022-08-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 022288
application number: NDA022288
ndc (product): 24208-629
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
Bepreve
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863038Internal RxNorm lookup
863042Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6Available 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
24208-629-01Bepreve1 in 1 CARTONSOLUTION/ DROPS114
24208-629-01Bepreve10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1014
24208-629-02Bepreve5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS514
24208-629-02Bepreve1 in 1 CARTONSOLUTION/ DROPS114
24208-629-03Bepreve1 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS114
24208-629-03Bepreve1 in 1 CARTONSOLUTION/ DROPS114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-629-01ML - Milliliter24208-62933b2df23-c223-4f4d-99ef-2add3c9c9ee312013-08-02
24208-629-02ML - Milliliter24208-62931d2db2f-eadf-4988-8ec7-fa72053396e612013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BEPOTASTINE BESILATEACTIVE INGREDIENT6W18MO1QR3BEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BEPOTASTINEACTIVE MOIETYHYD2U48IASBEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7BEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956BEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
WATERINACTIVE INGREDIENT059QF0KO0RBEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-629BEPREVE (BEPOTASTINE BESILATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]14Current NDC, Legacy NDC, 6 package rows20221022_68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863038bepotastine besilate 1.5 % Ophthalmic SolutionPSN68bbf6a0-c4b5-47c1-8a1c-08220fbdbce614
863042BEPREVE 1.5 % Ophthalmic SolutionPSN68bbf6a0-c4b5-47c1-8a1c-08220fbdbce614
863042bepotastine besilate 15 MG/ML Ophthalmic Solution [Bepreve]SBD68bbf6a0-c4b5-47c1-8a1c-08220fbdbce614
863038bepotastine besilate 15 MG/ML Ophthalmic SolutionSCD68bbf6a0-c4b5-47c1-8a1c-08220fbdbce614
863038bepotastine besilate 1.5 % Ophthalmic SolutionSY68bbf6a0-c4b5-47c1-8a1c-08220fbdbce614
863042Bepreve 1.5 % Ophthalmic SolutionSY68bbf6a0-c4b5-47c1-8a1c-08220fbdbce614
863042Bepreve 15 MG/ML Ophthalmic SolutionSY68bbf6a0-c4b5-47c1-8a1c-08220fbdbce614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-629-01242080629011 BOTTLE, DROPPER in 1 CARTON (24208-629-01) / 10 mL in 1 BOTTLE, DROPPER2009-09-080000-00-00NoNoCurrent
24208-629-02242080629021 BOTTLE, DROPPER in 1 CARTON (24208-629-02) / 5 mL in 1 BOTTLE, DROPPER2009-09-080000-00-00NoNoCurrent
24208-629-03242080629031 BOTTLE, DROPPER in 1 CARTON (24208-629-03) / 1 mL in 1 BOTTLE, DROPPER2009-09-080000-00-00NoNoCurrent