Alcohol Antibacterial Gel(none-rinse)
NDC Package 54345-002-01

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.

Alcohol Antibacterial Gel(none-rinse) is place enough product on hands to cover all surfaces. Marketed by Amicus Asia Pacific(hubei) Healthcare Products Pte Ltd, this product is identified by NDC 54345-002 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
54345-002-01
Package Description
80 mL in 1 BOTTLE
Product Code
54345-002
11-Digit Billing Format
54345000201

Clinical Specifications

Proprietary Name
Alcohol Antibacterial Gel(none-rinse)
Dosage Form
-
Usage Information
Place enough product on hands to cover all surfaces. Rub hands together until dry.

Regulatory & Marketing

Labeler Name
Amicus Asia Pacific(hubei) Healthcare Products Pte Ltd
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
07-03-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54345-002-01 identifies a specific commercial package of 80 ml in 1 bottle of Alcohol Antibacterial Gel(none-rinse), labeled by Amicus Asia Pacific(hubei) Healthcare Products Pte Ltd. 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 Amicus Asia Pacific(hubei) Healthcare Products Pte Ltd on July 03, 2020. The current certification is valid through December 31, 2021.

How is this Amicus Asia Pacific(hubei) Healthcare Products Pte Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54345000201. 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)
54345-002-01
11-Digit CMS (5-4-2)
54345-0002-01

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