Eyewash Solution
NDC Package 78641-786-67

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

Eyewash solution is remove tamper evident seal and capavoid contamination of rim and inside surfaces of the nozzleplace nozzle to the affected area and tilt the bottle to pour liquid out through the nozzleopen eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash. This formulation utilizes a solution delivery system. Marketed by Global Equipment Company, this product is identified by NDC 78641-786 and is authorized under FDA application NDA022305.

Identification & Billing

NDC Package Code
78641-786-67
Package Description
473 mL in 1 BOTTLE, UNIT-DOSE
Product Code
78641-786
11-Digit Billing Format
78641078667
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eyewash
Non-Proprietary Name
Eyewash
Substance Name
Water
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)
WATER 465 mL/473mL
Usage Information
Remove tamper evident seal and capavoid contamination of rim and inside surfaces of the nozzleplace nozzle to the affected area and tilt the bottle to pour liquid out through the nozzleopen eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Regulatory & Marketing

Labeler Name
Global Equipment Company
Product Type
Human Otc Drug
FDA Application #
NDA022305
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-17-2021
Listing Expiration
12-31-2026
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 (78641-786). Click a package code to view its specific billing and regulatory data.

78641-786-68
946 mL in 1 BOTTLE, UNIT-DOSE

* 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 78641-786-67 identifies a specific commercial package of 473 ml in 1 bottle, unit-dose of Eyewash, a human over the counter drug labeled by Global Equipment Company. This solution is formulated for ophthalmic use and contains water 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 Global Equipment Company on June 17, 2021. The current certification is valid through December 31, 2026.

How is this Global Equipment Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78641078667. 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)
78641-786-67
11-Digit CMS (5-4-2)
78641-0786-67

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