altafluor

Generic: fluorescein sodium and benoxinate hydrochloride

Labeler: altaire pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name altafluor
Generic Name fluorescein sodium and benoxinate hydrochloride
Labeler altaire pharmaceuticals inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

benoxinate hydrochloride 4 mg/mL, fluorescein sodium 2.5 mg/mL

Manufacturer
Altaire Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59390-218
Product ID 59390-218_22a50c28-e476-4966-b68c-065a4b8e157f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208582
Listing Expiration 2026-12-31
Marketing Start 2018-03-01

Pharmacologic Class

Classes
diagnostic dye [epc] dyes [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59390218
Hyphenated Format 59390-218

Supplemental Identifiers

RxCUI
2099132 2099522
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 altafluor (source: ndc)
Generic Name fluorescein sodium and benoxinate hydrochloride (source: ndc)
Application Number NDA208582 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
  • 2.5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (59390-218-05)
source: ndc

Packages (1)

59390-218-05 5 mL in 1 BOTTLE, DROPPER (59390-218-05)

Ingredients (2)

benoxinate hydrochloride (4 mg/mL) fluorescein sodium (2.5 mg/mL)

Linked Drug Pages (1)

ALTAFLUOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "22a50c28-e476-4966-b68c-065a4b8e157f", "openfda": {"unii": ["0VE4U49K15", "93X55PE38X"], "rxcui": ["2099132", "2099522"], "spl_set_id": ["54017304-e680-4129-b52a-69cb9810af76"], "manufacturer_name": ["Altaire Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (59390-218-05)", "package_ndc": "59390-218-05", "marketing_start_date": "20180301"}], "brand_name": "ALTAFLUOR", "product_id": "59390-218_22a50c28-e476-4966-b68c-065a4b8e157f", "dosage_form": "SOLUTION", "pharm_class": ["Diagnostic Dye [EPC]", "Dyes [MoA]"], "product_ndc": "59390-218", "generic_name": "Fluorescein Sodium and Benoxinate Hydrochloride", "labeler_name": "Altaire Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALTAFLUOR", "active_ingredients": [{"name": "BENOXINATE HYDROCHLORIDE", "strength": "4 mg/mL"}, {"name": "FLUORESCEIN SODIUM", "strength": "2.5 mg/mL"}], "application_number": "NDA208582", "marketing_category": "NDA", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}