Stefano Gladius
NDC Package 69772-040-01

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.

Stefano Gladius is dIRECTIONSAPPLY UNDER ARM ONLYSHAKE WELL BEFORE USE. Marketed by Teresa Cecena Dba Genesis, this product is identified by NDC 69772-040 and is authorized under FDA application part350.

Identification & Billing

NDC Package Code
69772-040-01
Package Description
50 mL in 1 APPLICATOR
Product Code
69772-040
11-Digit Billing Format
69772004001

Clinical Specifications

Proprietary Name
Stefano Gladius Roll-on
Dosage Form
-
Usage Information
DIRECTIONSAPPLY UNDER ARM ONLYSHAKE WELL BEFORE USE

Regulatory & Marketing

Labeler Name
Teresa Cecena Dba Genesis
FDA Application #
part350
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-02-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69772-040-01 identifies a specific commercial package of 50 ml in 1 applicator of Stefano Gladius Roll-on, labeled by Teresa Cecena Dba Genesis. 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 Teresa Cecena Dba Genesis on June 02, 2015. The current certification is valid through December 31, 2017.

How is this Teresa Cecena Dba Genesis product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69772004001. 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)
69772-040-01
11-Digit CMS (5-4-2)
69772-0040-01

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