NDC 51801-008 Dry Eye Test

Fluorescein Sodium

NDC Product Information

Dry Eye Test with NDC 51801-008 is a a human prescription drug product labeled by Nomax Inc.. The generic name of Dry Eye Test is fluorescein sodium. The product's dosage form is strip and is administered via ophthalmic form.

Labeler Name: Nomax Inc.

Dosage Form: Strip - A long narrow piece of material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Dry Eye Test Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FLUORESCEIN SODIUM .12 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Diagnostic Dye - [EPC] (Established Pharmacologic Class)
  • Dyes - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nomax Inc.
Labeler Code: 51801
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-05-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dry Eye Test Product Label Images

Dry Eye Test Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Dry Eye Test Fluorescein Sodium Ophthalmic Strips U.S.P. diagnostic agent is for professional use onlyEach strip is impregnated with 0.12 mg of fluorescein sodium USP.

NOTE: The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C.

Indications

For testing tear film stability by determining the fluorescein break-up time (FBUT).

Contraindications

Hypersensitivity to components or mercury-containing compounds.

Directions For Use

Procedure for measuring FluoresceinBreak-up Time (FBUT) with Amcon Dry Eye Test Strips.1. Apply one or two drops of non-preserved saline to theimpregnated paper tip. Excess fluid will automatically fall off.Shaking is neitherrequired nor desirable.2. Ask the patient to look down and in.3. Gently touch the strip to the superior temporal bulbar conjunctivafor one or two seconds.4. Ask the patient to blink three times and open eyes naturally.5. Conduct the FBUT measurements immediately.6. Perform two consecutive measurements. If not consistent, conducta third and average the results.7. Repeat steps 1 through 6 using a new strip for the second eyeFBUT values of less than 10 seconds are considered abnormal. Values less than 5 seconds are indicative of dry eye disorder. Values of 5 to 9 seconds are borderline dry eye.

How Supplied

Carton of 50 pouches of two strips each.

* Please review the disclaimer below.