besivance

Generic: besifloxacin

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

Drug Facts

Product Profile

Brand Name besivance
Generic Name besifloxacin
Labeler bausch & lomb americas inc.
Dosage Form SUSPENSION
Routes
OPHTHALMIC
Active Ingredients

besifloxacin 6 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-466
Product ID 82260-466_483360bc-332c-6ccd-e063-6394a90a0b25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022308
Listing Expiration 2027-12-31
Marketing Start 2026-01-09

Pharmacologic Class

Established (EPC)
quinolone antimicrobial [epc]
Chemical Structure
quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260466
Hyphenated Format 82260-466

Supplemental Identifiers

UNII
BFE2NBZ7NX
NUI
N0000175937 M0023650

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 besivance (source: ndc)
Generic Name besifloxacin (source: ndc)
Application Number NDA022308 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-466-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

Ingredients (1)

besifloxacin (6 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "483360bc-332c-6ccd-e063-6394a90a0b25", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["BFE2NBZ7NX"], "spl_set_id": ["ff971287-5610-4f15-8392-fc974e6ff646"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-466-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-466-05", "marketing_start_date": "20260109"}], "brand_name": "Besivance", "product_id": "82260-466_483360bc-332c-6ccd-e063-6394a90a0b25", "dosage_form": "SUSPENSION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "82260-466", "generic_name": "Besifloxacin", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Besivance", "active_ingredients": [{"name": "BESIFLOXACIN", "strength": "6 mg/mL"}], "application_number": "NDA022308", "marketing_category": "NDA", "marketing_start_date": "20260109", "listing_expiration_date": "20271231"}