Freshkote Preservative Free Lubricant Eye Drops Solution
NDC Package 71776-001-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Freshkote Preservative Free Lubricant Eye Drops (povidone, polyvinyl alcohol) solution is usesFor use as a lubricant to reduce further irritation or to relieve dryness of the eye. This formulation utilizes a solution delivery system. Marketed by Eyevance Pharmaceuticals, this product is identified by NDC 71776-001 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
71776-001-10
Package Description
1 BOTTLE, DROPPER in 1 BOX / 10 mL in 1 BOTTLE, DROPPER
Product Code
71776-001
11-Digit Billing Format
71776000110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Freshkote Preservative Free Lubricant Eye Drops
Non-Proprietary Name
Povidone, Polyvinyl Alcohol
Substance Name
Polyvinyl Alcohol, Unspecified; Povidone
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Usage Information
UsesFor use as a lubricant to reduce further irritation or to relieve dryness of the eye

Regulatory & Marketing

Labeler Name
Eyevance Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-13-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71776-001). Click a package code to view its specific billing and regulatory data.

71776-001-03
30 VIAL, SINGLE-USE in 1 BOX / .3 mL in 1 VIAL, SINGLE-USE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71776-001-10 identifies a specific commercial package of 1 bottle, dropper in 1 box / 10 ml in 1 bottle, dropper of Freshkote Preservative Free Lubricant Eye Drops, a human over the counter drug labeled by Eyevance Pharmaceuticals. This solution is formulated for ophthalmic use and contains polyvinyl alcohol, unspecified; povidone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Eyevance Pharmaceuticals on March 13, 2019. The current certification is valid through December 31, 2027.

How is this Eyevance Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71776000110. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71776-001-10
11-Digit CMS (5-4-2)
71776-0001-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.