Guardex Hand Sanitizer Antiseptic Solution
NDC Package 80307-002-33

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.

Guardex Hand Sanitizer Antiseptic Solution is place enough product on hands to cover all surfaces.Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing. Marketed by Guardex Labs, Inc., this product is identified by NDC 80307-002 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
80307-002-33
Package Description
1000 mL in 1 BOTTLE
Product Code
80307-002
11-Digit Billing Format
80307000233
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Guardex Hand Sanitizer Antiseptic Solution
Dosage Form
-
Usage Information
Place enough product on hands to cover all surfaces.Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Guardex Labs, Inc.
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
07-01-2020
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 (80307-002). Click a package code to view its specific billing and regulatory data.

80307-002-04
118 mL in 1 BOTTLE
80307-002-08
250 mL in 1 BOTTLE
80307-002-16
500 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 80307-002-33 identifies a specific commercial package of 1000 ml in 1 bottle of Guardex Hand Sanitizer Antiseptic Solution, labeled by Guardex Labs, 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 Guardex Labs, Inc. on July 01, 2020. The current certification is valid through December 31, 2021.

How is this Guardex Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80307000233. 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)
80307-002-33
11-Digit CMS (5-4-2)
80307-0002-33

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