bepreve

Generic: bepotastine besilate

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bepreve
Generic Name bepotastine besilate
Labeler bausch & lomb incorporated
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bepotastine besylate 15 mg/mL

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-629
Product ID 24208-629_a4c88d72-eb17-446a-9da5-6bcf1263377f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022288
Listing Expiration 2026-12-31
Marketing Start 2009-09-08

Pharmacologic Class

Classes
histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208629
Hyphenated Format 24208-629

Supplemental Identifiers

RxCUI
863038 863042
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 bepreve (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 (24208-629-01) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-629-02) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-629-03) / 1 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

24208-629-01 1 BOTTLE, DROPPER in 1 CARTON (24208-629-01) / 10 mL in 1 BOTTLE, DROPPER 24208-629-02 1 BOTTLE, DROPPER in 1 CARTON (24208-629-02) / 5 mL in 1 BOTTLE, DROPPER 24208-629-03 1 BOTTLE, DROPPER in 1 CARTON (24208-629-03) / 1 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bepotastine besylate (15 mg/mL)

Linked Drug Pages (1)

Bepreve ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "a4c88d72-eb17-446a-9da5-6bcf1263377f", "openfda": {"unii": ["6W18MO1QR3"], "rxcui": ["863038", "863042"], "spl_set_id": ["68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-629-01)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-629-01", "marketing_start_date": "20090908"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-629-02)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-629-02", "marketing_start_date": "20090908"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-629-03)  / 1 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-629-03", "marketing_start_date": "20090908"}], "brand_name": "Bepreve", "product_id": "24208-629_a4c88d72-eb17-446a-9da5-6bcf1263377f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "24208-629", "generic_name": "bepotastine besilate", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bepreve", "active_ingredients": [{"name": "BEPOTASTINE BESYLATE", "strength": "15 mg/mL"}], "application_number": "NDA022288", "marketing_category": "NDA", "marketing_start_date": "20090908", "listing_expiration_date": "20261231"}