fluorescein sodium and benoxinate hydrochloride

Generic: fluorescein sodium and benoxinate hydrochloride

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

Drug Facts

Product Profile

Brand Name fluorescein sodium and benoxinate hydrochloride
Generic Name fluorescein sodium and benoxinate hydrochloride
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

benoxinate hydrochloride 4.4 mg/mL, fluorescein sodium 2.6 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-734
Product ID 82260-734_34f4e654-be4a-0c13-e063-6394a90a629d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA211039
Listing Expiration 2026-12-31
Marketing Start 2020-03-20

Pharmacologic Class

Classes
diagnostic dye [epc] dyes [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260734
Hyphenated Format 82260-734

Supplemental Identifiers

RxCUI
2287005
UNII
0VE4U49K15 93X55PE38X

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 fluorescein sodium and benoxinate hydrochloride (source: ndc)
Generic Name fluorescein sodium and benoxinate hydrochloride (source: ndc)
Application Number NDA211039 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4.4 mg/mL
  • 2.6 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (82260-734-05) / 5 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

82260-734-05 1 BOTTLE, GLASS in 1 CARTON (82260-734-05) / 5 mL in 1 BOTTLE, GLASS

Ingredients (2)

benoxinate hydrochloride (4.4 mg/mL) fluorescein sodium (2.6 mg/mL)

Linked Drug Pages (1)

Fluorescein Sodium and Benoxinate Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "34f4e654-be4a-0c13-e063-6394a90a629d", "openfda": {"unii": ["0VE4U49K15", "93X55PE38X"], "rxcui": ["2287005"], "spl_set_id": ["f935b5f8-dc6e-4425-a668-968ee3855f51"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (82260-734-05)  / 5 mL in 1 BOTTLE, GLASS", "package_ndc": "82260-734-05", "marketing_start_date": "20200320"}], "brand_name": "Fluorescein Sodium and Benoxinate Hydrochloride", "product_id": "82260-734_34f4e654-be4a-0c13-e063-6394a90a629d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Diagnostic Dye [EPC]", "Dyes [MoA]"], "product_ndc": "82260-734", "generic_name": "Fluorescein Sodium and Benoxinate Hydrochloride", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorescein Sodium and Benoxinate Hydrochloride", "active_ingredients": [{"name": "BENOXINATE HYDROCHLORIDE", "strength": "4.4 mg/mL"}, {"name": "FLUORESCEIN SODIUM", "strength": "2.6 mg/mL"}], "application_number": "NDA211039", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20200320", "listing_expiration_date": "20261231"}