Prefenz Silica Based Hand Sanitizer
NDC Package 48404-106-01

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.

Prefenz Silica Based Hand Sanitizer is directions: Apply to hands, rub together, and let dry.  Hands will be protected for up to 24 hours or up to 10 hand washings with only one application. Marketed by Prefense Llc, this product is identified by NDC 48404-106 and is authorized under FDA application part333.

Identification & Billing

NDC Package Code
48404-106-01
Package Description
44.36 mL in 1 BOTTLE
Product Code
48404-106
11-Digit Billing Format
48404010601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prefenz Silica Based Hand Sanitizer
Dosage Form
-
Usage Information
Directions: Apply to hands, rub together, and let dry.  Hands will be protected for up to 24 hours or up to 10 hand washings with only one application.

Regulatory & Marketing

Labeler Name
Prefense Llc
FDA Application #
part333
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-2009
Listing Expiration
12-31-2017
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 (48404-106). Click a package code to view its specific billing and regulatory data.

48404-106-02
236.588 mL in 1 BOTTLE
48404-106-03
1892.7 mL in 1 BOTTLE
48404-106-04
946.35 mL in 1 BOTTLE

* 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 48404-106-01 identifies a specific commercial package of 44.36 ml in 1 bottle of Prefenz Silica Based Hand Sanitizer, labeled by Prefense Llc. 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 Prefense Llc on January 01, 2009. The current certification is valid through December 31, 2017.

How is this Prefense Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48404010601. 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)
48404-106-01
11-Digit CMS (5-4-2)
48404-0106-01

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