FDA.reportPublic FDA data

Bepotastine Besilate

Product NDC
0378-7055
11-digit product format
003787055
Labeler code
0378
Product ID
0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bepotastine Besilate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206220
Marketing category
ANDA
Marketing start
2021-05-28
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
A206220-001BEPOTASTINE BESILATEBEPOTASTINE BESILATE1.5%SOLUTION/DROPS / OPHTHALMICAT2019-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206220-001AT

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 22:54:322026-06A206220-001BEPOTASTINE BESILATE1.5%SOLUTION/DROPS / OPHTHALMICAT2019-03-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206220-001AT1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bepotastine BesilateBEPOTASTINE BESILATEMylan Pharmaceuticals Inc.75178670-aa57-45f9-94d5-efcf8305e6832018-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206220
application number: ANDA206220
ndc (product): 0378-7055

Additional Listing Data#

Finished product
Yes
Brand name base
Bepotastine Besilate
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
75178670-aa57-45f9-94d5-efcf8305e683Available 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
0378-7055-35Bepotastine Besilate1 in 1 CARTONSOLUTION/ DROPS14
0378-7055-35Bepotastine Besilate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54
0378-7055-67Bepotastine Besilate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS104
0378-7055-67Bepotastine Besilate1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7055-35ML - Milliliter0378-705594e7f5fa-f0cf-4705-b925-ec356fa5527b12021-06-02
0378-7055-67ML - Milliliter0378-7055e7f8f470-32b9-4e34-8986-a0cf9ebae8cb12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7055BEPOTASTINE BESILATE SOLUTION/ DROPS [MYLAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 4 package rows20210529_75178670-aa57-45f9-94d5-efcf8305e683.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863038bepotastine besilate 1.5 % Ophthalmic SolutionPSN75178670-aa57-45f9-94d5-efcf8305e6834
863038bepotastine besilate 15 MG/ML Ophthalmic SolutionSCD75178670-aa57-45f9-94d5-efcf8305e6834
863038bepotastine besilate 1.5 % Ophthalmic SolutionSY75178670-aa57-45f9-94d5-efcf8305e6834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-7055-35003787055351 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPER2021-05-280000-00-00NoNoCurrent
0378-7055-67003787055671 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPER2021-05-280000-00-00NoNoCurrent