Eyesaline Concentrate
NDC Package 64809-104-18

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Eyesaline Concentrate is concentrate must be diluted (1) part concentrate to (10) parts potable water before usePrepare sufficient quantity of constituted eyewash solution in advance of an emergencyMix concentrate with potable water to prepare eyewash solution as follows:Determine quantity of eyewash solution requiredFollow sanitary proceduresWear protective eyewear and glovesPour 1/3 of required amount of potable water into mixing container or eyewash unitAdd 1/3 of required amount of concentrate to waterAgitate or mix thoroughly​Repeat until required amount of solution is preparedProperly dispose of empty bottle after useDo not reuse.Replace solution no longer than (6) months after mixing. Marketed by Sperian Eye & Face Protection Inc., this product is identified by NDC 64809-104 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
64809-104-18
Package Description
2070 mL in 1 BOTTLE, PLASTIC
Product Code
64809-104
11-Digit Billing Format
64809010418
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eyesaline Concentrate
Dosage Form
-
Usage Information
Concentrate must be diluted (1) part concentrate to (10) parts potable water before usePrepare sufficient quantity of constituted eyewash solution in advance of an emergencyMix concentrate with potable water to prepare eyewash solution as follows:Determine quantity of eyewash solution requiredFollow sanitary proceduresWear protective eyewear and glovesPour 1/3 of required amount of potable water into mixing container or eyewash unitAdd 1/3 of required amount of concentrate to waterAgitate or mix thoroughly​Repeat until required amount of solution is preparedProperly dispose of empty bottle after useDo not reuse.Replace solution no longer than (6) months after mixing

Regulatory & Marketing

Labeler Name
Sperian Eye & Face Protection Inc.
FDA Application #
part349
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-08-2011
Listing Expiration
12-31-2019
Exclude Flag
I
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 (64809-104). Click a package code to view its specific billing and regulatory data.

64809-104-19
5323 mL in 1 BOTTLE, PLASTIC

* 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 64809-104-18 identifies a specific commercial package of 2070 ml in 1 bottle, plastic of Eyesaline Concentrate, labeled by Sperian Eye & Face Protection Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sperian Eye & Face Protection Inc. on September 08, 2011. The current certification is valid through December 31, 2019.

How is this Sperian Eye & Face Protection Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64809010418. 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)
64809-104-18
11-Digit CMS (5-4-2)
64809-0104-18

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