Home NDC 0378-7055 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 2027-12-31
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 A206220-001 BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206220-001 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 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206220-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 2027-12-31 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 0378-7055-35 Bepotastine Besilate 1 in 1 CARTON SOLUTION/ DROPS 1 4 0378-7055-35 Bepotastine Besilate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 4 0378-7055-67 Bepotastine Besilate 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 4 0378-7055-67 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 0378-7055 BEPOTASTINE BESILATE SOLUTION/ DROPS [MYLAN PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 4 package rows 20210529_75178670-aa57-45f9-94d5-efcf8305e683.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 · 1 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 0378-7055-35 00378705535 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPER 2021-05-28 0000-00-00 No No Current 0378-7055-67 00378705567 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPER 2021-05-28 0000-00-00 No No Current