bepotastine besilate

Generic: bepotastine besilate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bepotastine besilate
Generic Name bepotastine besilate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

bepotastine besilate 15 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-712
Product ID 70069-712_32be8aa1-ad8e-4840-8d22-49316257cda4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217770
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

Classes
histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069712
Hyphenated Format 70069-712

Supplemental Identifiers

RxCUI
863038
UPC
0370069712016 0370069711019
UNII
6W18MO1QR3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bepotastine besilate (source: ndc)
Generic Name bepotastine besilate (source: ndc)
Application Number ANDA217770 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-712-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-712-01 1 BOTTLE in 1 CARTON (70069-712-01) / 10 mL in 1 BOTTLE

Ingredients (1)

bepotastine besilate (15 mg/mL)

Linked Drug Pages (1)

Bepotastine Besilate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "32be8aa1-ad8e-4840-8d22-49316257cda4", "openfda": {"upc": ["0370069712016", "0370069711019"], "unii": ["6W18MO1QR3"], "rxcui": ["863038"], "spl_set_id": ["cd6a061d-8ad7-4ad1-b039-1e3aa3435d32"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-712-01)  / 10 mL in 1 BOTTLE", "package_ndc": "70069-712-01", "marketing_start_date": "20241010"}], "brand_name": "Bepotastine Besilate", "product_id": "70069-712_32be8aa1-ad8e-4840-8d22-49316257cda4", "dosage_form": "SOLUTION", "pharm_class": ["Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70069-712", "generic_name": "Bepotastine Besilate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bepotastine Besilate", "active_ingredients": [{"name": "BEPOTASTINE BESILATE", "strength": "15 mg/mL"}], "application_number": "ANDA217770", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}