Home NDC 82260-630 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 43 .
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 N022288-001 BEPREVE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022288-001 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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2009-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2009-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2009-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2009-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022288-001 BEPREVE 1.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2009-09-08 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 67 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022288-001 6780877 2019-09-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022288-001 8784789 2024-09-05 Drug product 2014-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022288-001 8784789 2025-01-13 Drug product 2014-07-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022288-001 6780877 2019-09-19 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022288-001 8784789 2024-09-05 Drug product 2014-07-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022288-001 6780877 2019-09-19 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022288-001 8877168 2023-07-30 Drug product 2014-11-25 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022288-001 8784789 2024-09-05 Drug product 2014-07-22 b00525d2431f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Bepotastine Besilate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEPOTASTINE BESYLATE 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 82260-630-05 Bepotastine Besilate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 4 82260-630-05 Bepotastine Besilate 1 in 1 CARTON SOLUTION/ DROPS 1 4 82260-630-10 Bepotastine Besilate 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 4 82260-630-10 Bepotastine Besilate 1 in 1 CARTON SOLUTION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82260-630 BEPOTASTINE BESILATE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.] 4 Current NDC, Legacy NDC, 4 package rows 20240822_70430ab5-cd0a-451e-acab-347a2f981898.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 82260-630-05 82260063005 1 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER 2021-05-28 0000-00-00 No No Current 82260-630-10 82260063010 1 BOTTLE, DROPPER in 1 CARTON (82260-630-10) / 10 mL in 1 BOTTLE, DROPPER 2021-05-28 0000-00-00 No No Current