NDC 54799-507

FLUCAINE

Fluorescein Sodium And Proparacaine Hydrochloride

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

• Product ID: 54799-507_5f0e087e-73bf-4337-b49e-a566c12bcd0d
• NDC: 54799-507
• Product Type: Human Prescription Drug
• Proprietary Name: FLUCAINE
• Generic Name: Fluorescein Sodium And Proparacaine Hydrochloride
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1989-03-30
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: OCuSOFT, Inc.
• Substance Name: FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/mL; mg/mL
• Pharm Classes: Diagnostic Dye [EPC],Dyes [MoA],Local Anesthesia [PE],Local Anesthetic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54799-507-21

1 BOTTLE, DROPPER in 1 CARTON (54799-507-21) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2018-12-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54799-507-21 [54799050721]

FLUCAINE SOLUTION/ DROPS

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-12-28
• Marketing End Date: 2019-07-16

Drug Details

Active Ingredients

Ingredient	Strength
FLUORESCEIN SODIUM	2.5 mg/mL

OpenFDA Data

• SPL SET ID: 71a652d5-ba61-4f0e-8f62-1dc2b8d3b231
• Manufacturer:
  • OCuSOFT, Inc.
• UNII:
  • U96OL57GOY
  • 93X55PE38X
• RxNorm Concept Unique ID - RxCUI:
  • 1247576
  • 1247445
• UPC Code:
  • 0315718507216

Pharmacological Class

• Diagnostic Dye [EPC]
• Dyes [MoA]
• Local Anesthesia [PE]
• Local Anesthetic [EPC]
• Diagnostic Dye [EPC]
• Dyes [MoA]
• Local Anesthesia [PE]
• Local Anesthetic [EPC]

NDC Crossover Matching brand name "FLUCAINE" or generic name "Fluorescein Sodium And Proparacaine Hydrochloride"

NDC	Brand Name	Generic Name
54799-507	FLUCAINE	Fluorescein Sodium and Proparacaine Hydrochloride
59390-205	Fluorescein Sodium and Proparacaine Hydrochloride	Fluorescein Sodium and Proparacaine Hydrochloride