bepotastine besilate

Generic: bepotastine besilate

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name bepotastine besilate
Generic Name bepotastine besilate
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bepotastine besylate 15 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-630
Product ID 82260-630_202287f2-01bc-1d43-e063-6294a90a8da1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022288
Listing Expiration 2026-12-31
Marketing Start 2021-05-28

Pharmacologic Class

Classes
histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260630
Hyphenated Format 82260-630

Supplemental Identifiers

RxCUI
863038
UPC
0382260630051
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 NDA022288 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-630-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82260-630-05 1 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER 82260-630-10 1 BOTTLE, DROPPER in 1 CARTON (82260-630-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bepotastine besylate (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": "202287f2-01bc-1d43-e063-6294a90a8da1", "openfda": {"upc": ["0382260630051"], "unii": ["6W18MO1QR3"], "rxcui": ["863038"], "spl_set_id": ["70430ab5-cd0a-451e-acab-347a2f981898"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-630-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-630-05", "marketing_start_date": "20210528"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-630-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-630-10", "marketing_start_date": "20210528"}], "brand_name": "Bepotastine Besilate", "product_id": "82260-630_202287f2-01bc-1d43-e063-6294a90a8da1", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "82260-630", "generic_name": "bepotastine besilate", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bepotastine Besilate", "active_ingredients": [{"name": "BEPOTASTINE BESYLATE", "strength": "15 mg/mL"}], "application_number": "NDA022288", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20210528", "listing_expiration_date": "20261231"}