bepotastine besilate

Generic: bepotastine besilate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bepotastine besilate
Generic Name bepotastine besilate
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bepotastine besilate 15 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7055
Product ID 0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206220
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 03787055
Hyphenated Format 0378-7055

Supplemental Identifiers

RxCUI
863038
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 ANDA206220 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

0378-7055-35 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPER 0378-7055-67 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPER

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": "c8ce95fa-e800-433e-8d40-70a6b1e06140", "openfda": {"unii": ["6W18MO1QR3"], "rxcui": ["863038"], "spl_set_id": ["75178670-aa57-45f9-94d5-efcf8305e683"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0378-7055-35)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0378-7055-35", "marketing_start_date": "20210528"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0378-7055-67)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0378-7055-67", "marketing_start_date": "20210528"}], "brand_name": "Bepotastine Besilate", "product_id": "0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0378-7055", "generic_name": "Bepotastine Besilate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bepotastine Besilate", "active_ingredients": [{"name": "BEPOTASTINE BESILATE", "strength": "15 mg/mL"}], "application_number": "ANDA206220", "marketing_category": "ANDA", "marketing_start_date": "20210528", "listing_expiration_date": "20261231"}