NDC 54799-508

Flurox

Fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg (0.4%)

Flurox is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Ocusoft, Inc.. The primary component is Fluorescein Sodium; Benoxinate Hydrochloride.

• Product ID: 54799-508_5476a07b-4f5c-3b6b-38b3-b006435306c1
• NDC: 54799-508
• Product Type: Human Prescription Drug
• Proprietary Name: Flurox
• Generic Name: Fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg (0.4%)
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-01-29
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: OCuSOFT, Inc.
• Substance Name: FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/mL; mg/mL
• Pharm Classes: Diagnostic Dye [EPC],Dyes [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54799-508-05

5 mL in 1 BOTTLE, DROPPER (54799-508-05)

• Marketing Start Date: 2014-01-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54799-508-05 [54799050805]

Flurox SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-29
• Marketing End Date: 2018-02-08

Drug Details

Active Ingredients

Ingredient	Strength
FLUORESCEIN SODIUM	2.5 mg/mL

OpenFDA Data

• SPL SET ID: 900ec4c1-e5e3-e940-5b02-cf2589955e20
• Manufacturer:
  • OCuSOFT, Inc.
• UNII:
  • 0VE4U49K15
  • 93X55PE38X
• RxNorm Concept Unique ID - RxCUI:
  • 2099528
  • 2099132

Pharmacological Class

• Diagnostic Dye [EPC]
• Dyes [MoA]