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  4. NDC Product Code: 15821-105 Freshkote Preservative Free Lubricating Eye Drops Single Use

NDC 15821-105 Freshkote Preservative Free Lubricating Eye Drops Single Use

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 15821-105?
  4. Freshkote Preservative Free Lubricating Eye Drops Single Use Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
15821-105
Proprietary Name:
Freshkote Preservative Free Lubricating Eye Drops Single Use
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Focus Laboratories, Inc.
Labeler Code:
15821
Product Label ID:
be2f3b44-f371-4504-86d3-292cc8dfa062
Start Marketing Date: [9]
06-29-2018
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
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Product Details

What is NDC 15821-105?

The NDC code 15821-105 is assigned by the FDA to the product Freshkote Preservative Free Lubricating Eye Drops Single Use which is product labeled by Focus Laboratories, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 15821-105-03 6 pouch in 1 box / 5 bottle, unit-dose in 1 pouch / .3 ml in 1 bottle, unit-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Freshkote Preservative Free Lubricating Eye Drops Single Use?

For the temporary relief of discomfort due to minor irritations of the eye or to exposure of wind or sun

Which are Freshkote Preservative Free Lubricating Eye Drops Single Use UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Freshkote Preservative Free Lubricating Eye Drops Single Use Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Freshkote Preservative Free Lubricating Eye Drops Single Use?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 630977 - polyvinyl alcohol 2.7 % / povidone 2 % Ophthalmic Solution
  • RxCUI: 630977 - polyvinyl alcohol 27 MG/ML / povidone 20 MG/ML Ophthalmic Solution
  • RxCUI: 630981 - FreshKote 2.7 % / 2 % Ophthalmic Solution
  • RxCUI: 630981 - polyvinyl alcohol 27 MG/ML / povidone 20 MG/ML Ophthalmic Solution [Freshkote]
  • RxCUI: 630981 - Freshkote (polyvinyl alcohol 1.8 % / polyvinyl alcohol 0.9 % / povidone 2 % ) Ophthalmic Solution

* Please review the disclaimer below.

Product Footnotes

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

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".