Home NDC 70069-711 Bepotastine Besilate
Product NDC 70069-711
11-digit product format 700690711
Labeler code 70069
Product ID 70069-711_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 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 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 2026-08-01 22:54:32 2026-06 A217770-001 BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-08-14 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 A217770-001 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 · 1 matching rows.
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 70069-711-01 Bepotastine Besilate 5 mL in 1 BOTTLE SOLUTION 5 4 70069-711-01 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 70069-711 BEPOTASTINE BESILATE SOLUTION [SOMERSET THERAPEUTICS, LLC] 4 Current NDC, 2 package rows 20241012_cd6a061d-8ad7-4ad1-b039-1e3aa3435d32.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 70069-711-01 70069071101 1 BOTTLE in 1 CARTON (70069-711-01) / 5 mL in 1 BOTTLE 1 bottle 2024-10-10 No No Current