Gabgerm Antisec Hand Sanitizer
NDC Package 80284-002-01

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.

Gabgerm Antisec Hand Sanitizer is wet hands thoroughly with product and allow to dry without wiping. Marketed by International Biotech Factory, S.a. De C.v., this product is identified by NDC 80284-002 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
80284-002-01
Package Description
1 BOTTLE in 1 BOX / 500 mL in 1 BOTTLE
Product Code
80284-002
11-Digit Billing Format
80284000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gabgerm Antisec Hand Sanitizer
Dosage Form
-
Usage Information
Wet hands thoroughly with product and allow to dry without wiping.

Regulatory & Marketing

Labeler Name
International Biotech Factory, S.a. De C.v.
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-04-2021
Listing Expiration
12-31-2024
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 (80284-002). Click a package code to view its specific billing and regulatory data.

80284-002-02
1 BOTTLE in 1 BOX / 1000 mL in 1 BOTTLE
80284-002-03
1 BOTTLE in 1 BOX / 250 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 80284-002-01 identifies a specific commercial package of 1 bottle in 1 box / 500 ml in 1 bottle of Gabgerm Antisec Hand Sanitizer, labeled by International Biotech Factory, S.a. De C.v.. 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 International Biotech Factory, S.a. De C.v. on January 04, 2021. The current certification is valid through December 31, 2024.

How is this International Biotech Factory, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80284000201. 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)
80284-002-01
11-Digit CMS (5-4-2)
80284-0002-01

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