Eyewash Station Additive Concentrate Liquid
NDC Package 65785-034-01

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

Package Information

Eyewash Station Additive Concentrate (chlorhexidine gluconate and propylene glycol) liquids is wear protective eyewear and glovesclean potable eyewash station and rinse with potable waterpartially fill station with potable waterremove tamper evident seal and cap of bottleadd entire contents of the bottle to the eyewash station containerfill the station to the manufacturer's required leveldate and initial inspection tagstation should be cleaned and refilled every 120 days when using this productin advance of emergency, add the concentrate to potable water to have a solution available. This formulation utilizes a liquid delivery system. Marketed by Niagara Pharmaceuticals Inc., this product is identified by NDC 65785-034 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
65785-034-01
Package Description
.236 L in 1 BOTTLE, UNIT-DOSE
Product Code
65785-034
11-Digit Billing Format
65785003401

Clinical Specifications

Proprietary Name
Eyewash Station Additive Concentrate
Non-Proprietary Name
Chlorhexidine Gluconate And Propylene Glycol
Substance Name
Chlorhexidine Gluconate; Propylene Glycol
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
Usage Information
Wear protective eyewear and glovesclean potable eyewash station and rinse with potable waterpartially fill station with potable waterremove tamper evident seal and cap of bottleadd entire contents of the bottle to the eyewash station containerfill the station to the manufacturer's required leveldate and initial inspection tagstation should be cleaned and refilled every 120 days when using this productin advance of emergency, add the concentrate to potable water to have a solution available

Regulatory & Marketing

Labeler Name
Niagara Pharmaceuticals Inc.
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-15-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65785-034-01 identifies a specific commercial package of .236 l in 1 bottle, unit-dose of Eyewash Station Additive Concentrate, a human over the counter drug labeled by Niagara Pharmaceuticals Inc.. This liquid is formulated for ophthalmic use and contains chlorhexidine gluconate; propylene glycol 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 Niagara Pharmaceuticals Inc. on November 15, 2011. The current certification is valid through December 31, 2026.

How is this Niagara Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65785003401. 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)
65785-034-01
11-Digit CMS (5-4-2)
65785-0034-01

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