Gelmex Black
NDC Package 80308-001-01

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.

Gelmex Black is a medication used as Antiseptic. Marketed by Grupo Siller Ingenier�a Construcci�n Y Materiales, S.a. De C.v, this product is identified by NDC 80308-001 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
80308-001-01
Package Description
5 mL in 1 POUCH
Product Code
80308-001
11-Digit Billing Format
80308000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gelmex Black
Dosage Form
-
Usage Information
This product is used as Antiseptic. Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Regulatory & Marketing

Labeler Name
Grupo Siller Ingenier�a Construcci�n Y Materiales, S.a. De C.v
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
08-31-2020
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 (80308-001). Click a package code to view its specific billing and regulatory data.

80308-001-02
250 mL in 1 BOTTLE, PLASTIC
80308-001-03
500 mL in 1 BOTTLE, PLASTIC

* 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 80308-001-01 identifies a specific commercial package of 5 ml in 1 pouch of Gelmex Black, labeled by Grupo Siller Ingenier�a Construcci�n Y Materiales, 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 Grupo Siller Ingenier�a Construcci�n Y Materiales, S.a. De C.v on August 31, 2020. The current certification is valid through December 31, 2021.

How is this Grupo Siller Ingenier�a Construcci�n Y Materiales, S.a. De C.v product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80308000101. 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)
80308-001-01
11-Digit CMS (5-4-2)
80308-0001-01

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