Home NDC 70069-712 Bepotastine Besilate
Product NDC 70069-712
11-digit product format 700690712
Labeler code 70069
Product ID 70069-712_32be8aa1-ad8e-4840-8d22-49316257cda4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bepotastine Besilate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Somerset Therapeutics, LLC
Application ANDA217770
Marketing category ANDA
Marketing start 2024-10-10
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 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 A217770-001 BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217770-001 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 2026-09-14 22:38:34 2026-08 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 a50c72e98297…
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 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 70069-712-01 Bepotastine Besilate 10 mL in 1 BOTTLE SOLUTION 10 4 70069-712-01 Bepotastine Besilate 1 in 1 CARTON SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-712 BEPOTASTINE BESILATE SOLUTION [SOMERSET THERAPEUTICS, LLC] 4 Current NDC, 2 package rows 20241012_cd6a061d-8ad7-4ad1-b039-1e3aa3435d32.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 Units Marketing start Sample Exclude flag Status 70069-712-01 70069071201 1 BOTTLE in 1 CARTON (70069-712-01) / 10 mL in 1 BOTTLE 1 bottle 2024-10-10 No No Current