Breakout Clearing Overnight Treatment
NDC Package 68479-313-01

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.

Breakout Clearing Overnight Treatment is clean the skin thoroughly before applying.Cover the affected area with a thin layer at night.Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week. Marketed by Dermalogica, Inc., this product is identified by NDC 68479-313 and is authorized under FDA application part358H.

Identification & Billing

NDC Package Code
68479-313-01
Package Description
14 mL in 1 TUBE
Product Code
68479-313
11-Digit Billing Format
68479031301

Clinical Specifications

Proprietary Name
Breakout Clearing Overnight Treatment
Dosage Form
-
Usage Information
Clean the skin thoroughly before applying.Cover the affected area with a thin layer at night.Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week.

Regulatory & Marketing

Labeler Name
Dermalogica, Inc.
FDA Application #
part358H
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-06-2013
Listing Expiration
12-31-2019
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 (68479-313). Click a package code to view its specific billing and regulatory data.

68479-313-00
2 mL in 1 POUCH
68479-313-02
1 TUBE in 1 CARTON / 59 mL in 1 TUBE

* 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 68479-313-01 identifies a specific commercial package of 14 ml in 1 tube of Breakout Clearing Overnight Treatment, labeled by Dermalogica, 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 Dermalogica, Inc. on September 06, 2013. The current certification is valid through December 31, 2019.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68479031301. 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)
68479-313-01
11-Digit CMS (5-4-2)
68479-0313-01

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