Home NDC 46708-598 Bepotastine Besilate Ophthalmic Solution 1.5%
Product NDC 46708-598
11-digit product format 467080598
Labeler code 46708
Product ID 46708-598_de111d74-c740-47b3-adc7-4b855df2c561
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bepotastine Besilate Ophthalmic Solution 1.5%
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alembic Pharmaceuticals Limited
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214588-001 BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2023-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214588-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A214588-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2023-04-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A214588-001 AT 1 a50c72e98297…
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.
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 Ingredient Strength BEPOTASTINE BESILATE 15 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6W18MO1QR3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863038 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-598-05 Bepotastine Besilate Ophthalmic Solution 1.5% 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 1 46708-598-05 Bepotastine Besilate Ophthalmic Solution 1.5% 1 in 1 CARTON SOLUTION/ DROPS 1 1 46708-598-10 Bepotastine Besilate Ophthalmic Solution 1.5% 1 in 1 CARTON SOLUTION/ DROPS 1 1 46708-598-10 Bepotastine Besilate Ophthalmic Solution 1.5% 10 mL in 1 BOTTLE SOLUTION/ DROPS 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-598 BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20230722_de111d74-c740-47b3-adc7-4b855df2c561.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-598-05 46708059805 1 BOTTLE in 1 CARTON (46708-598-05) / 5 mL in 1 BOTTLE 1 bottle 2023-07-18 No No Current 46708-598-10 46708059810 1 BOTTLE in 1 CARTON (46708-598-10) / 10 mL in 1 BOTTLE 1 bottle 2023-04-05 No No Current