Dermisa
NDC Package 68343-005-01

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.

Dermisa is • Adults Apply a small amount as a thin layer to the affected areas twice daily or as directed by a doctor. Marketed by Montani Cosmetics Inc, this product is identified by NDC 68343-005 and is authorized under FDA application part358A.

Identification & Billing

NDC Package Code
68343-005-01
Package Description
1 TUBE in 1 BOX / 50 g in 1 TUBE (68343-005-50)
Product Code
68343-005
11-Digit Billing Format
68343000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dermisa Skin Fade Vitamin C Infused
Dosage Form
-
Usage Information
• Adults Apply a small amount as a thin layer to the affected areas twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.Lightening effect of this product may not be noticeable when used on very dark skin. • Children under 12 years of age Do not use unless directed by a doctor • Sun exposure should be limited by using a sunscreen agent, or protective clothing to prevent bleached skin after treatment completed to prevent darkening from recurring

Regulatory & Marketing

Labeler Name
Montani Cosmetics Inc
FDA Application #
part358A
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
07-16-2018
Listing Expiration
12-31-2020
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 (68343-005). Click a package code to view its specific billing and regulatory data.

68343-005-02
1 TUBE in 1 BOX / 25 g in 1 TUBE (68343-005-25)

* 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 68343-005-01 identifies a specific commercial package of 1 tube in 1 box / 50 g in 1 tube (68343-005-50) of Dermisa Skin Fade Vitamin C Infused, labeled by Montani Cosmetics 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 Montani Cosmetics Inc on July 16, 2018. The current certification is valid through December 31, 2020.

How is this Montani Cosmetics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68343000501. 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)
68343-005-01
11-Digit CMS (5-4-2)
68343-0005-01

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