Eyefull Pcd Kit
NDC Package 80184-997-14

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.

Eyefull Pcd Kit is extract 1 wipe from pack, rub vigorously on and between fingers on both palms and hands, allow hands to dry.Discard in trash receptacle after use.Do not flush. Marketed by Rafac International Inc, this product is identified by NDC 80184-997 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
80184-997-14
Package Description
1 KIT in 1 KIT * 100 mL in 1 BOTTLE (80184-999-10) * 20 PATCH in 1 BAG (80184-996-10) / 3.5 mL in 1 PATCH
Product Code
80184-997
11-Digit Billing Format
80184099714
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eyefull Pcd Kit
Dosage Form
-
Usage Information
Extract 1 wipe from pack, rub vigorously on and between fingers on both palms and hands, allow hands to dry.Discard in trash receptacle after use.Do not flush.

Regulatory & Marketing

Labeler Name
Rafac International Inc
FDA Application #
part333E
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-29-2020
Listing Expiration
12-31-2021
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 (80184-997). Click a package code to view its specific billing and regulatory data.

80184-997-15
1 KIT in 1 KIT * 100 mL in 1 BOTTLE (80184-999-11) * 20 PATCH in 1 BAG (80184-996-11) / 3.5 mL in 1 PATCH

* 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 80184-997-14 identifies a specific commercial package of 1 kit in 1 kit * 100 ml in 1 bottle (80184-999-10) * 20 patch in 1 bag (80184-996-10) / 3.5 ml in 1 patch of Eyefull Pcd Kit, labeled by Rafac International 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 Rafac International Inc on August 29, 2020. The current certification is valid through December 31, 2021.

How is this Rafac International Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80184099714. 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)
80184-997-14
11-Digit CMS (5-4-2)
80184-0997-14

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