Antibacterial Wipes
NDC Package 78494-002-01

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

Package Information

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

Antibacterial Wipes is important! Do not open the top of the bag. Marketed by Fitguard, this product is identified by NDC 78494-002 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
78494-002-01
Package Description
1 CLOTH in 1 BAG
Product Code
78494-002
11-Digit Billing Format
78494000201

Clinical Specifications

Proprietary Name
Antibacterial Wipes
Dosage Form
-
Usage Information
Important! Do not open the top of the bag. 1. Cut a 1" opening into the top center of the bag along dashed line.2. Pull out the center wipe from the bag through the 1" hole.3. Place bag of wipes into the dispenser. 4. Thread the center wipe through the hole in the top of the dispenser. Take wipe and rub thoroughly over hands and other skin surfaces, allow to dry. Dispose of wipe after single use. Take wipe and rub thoroughly over hands and other skin surfaces, allow to dry. Dispose of wipe after single use.

Regulatory & Marketing

Labeler Name
Fitguard
FDA Application #
part333A
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
10-08-2020
Listing Expiration
12-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 78494-002-01 identifies a specific commercial package of 1 cloth in 1 bag of Antibacterial Wipes, labeled by Fitguard. 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 Fitguard on October 08, 2020. The current certification is valid through December 31, 2023.

How is this Fitguard product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78494000201. 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)
78494-002-01
11-Digit CMS (5-4-2)
78494-0002-01

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