fluorescite

Generic: fluorescein sodium

Labeler: alcon, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorescite
Generic Name fluorescein sodium
Labeler alcon, inc.
Dosage Form INJECTION, SOLUTION
Routes
OPHTHALMIC
Active Ingredients

fluorescein sodium 100 mg/mL

Manufacturer
Alcon, Inc.

Identifiers & Regulatory

Product NDC 0065-0092
Product ID 0065-0092_85861756-9727-4a43-8a4e-48564e341c48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021980
Listing Expiration 2026-12-31
Marketing Start 1972-09-15

Pharmacologic Class

Classes
diagnostic dye [epc] dyes [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650092
Hyphenated Format 0065-0092

Supplemental Identifiers

UNII
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 fluorescite (source: ndc)
Generic Name fluorescein sodium (source: ndc)
Application Number NDA021980 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL
source: ndc

Packages (1)

0065-0092-65 12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL

Ingredients (1)

fluorescein sodium (100 mg/mL)

Linked Drug Pages (1)

FLUORESCITE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "85861756-9727-4a43-8a4e-48564e341c48", "openfda": {"unii": ["93X55PE38X"], "spl_set_id": ["ebb3883c-71f6-4fd0-a7e6-0ba8e1136dd9"], "manufacturer_name": ["Alcon, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 VIAL in 1 CARTON (0065-0092-65)  / 5 mL in 1 VIAL", "package_ndc": "0065-0092-65", "marketing_start_date": "19720915"}], "brand_name": "FLUORESCITE", "product_id": "0065-0092_85861756-9727-4a43-8a4e-48564e341c48", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Diagnostic Dye [EPC]", "Dyes [MoA]"], "product_ndc": "0065-0092", "generic_name": "fluorescein sodium", "labeler_name": "Alcon, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUORESCITE", "active_ingredients": [{"name": "FLUORESCEIN SODIUM", "strength": "100 mg/mL"}], "application_number": "NDA021980", "marketing_category": "NDA", "marketing_start_date": "19720915", "listing_expiration_date": "20261231"}