Azelex
NDC Package 54868-4442-0

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.

Azelex is a medication used to treat mild to moderate acne. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4442 and is authorized under FDA application NDA020428.

Identification & Billing

NDC Package Code
54868-4442-0
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
54868-4442
11-Digit Billing Format
54868444200
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azelex
Dosage Form
-
Usage Information
This medication is used to treat mild to moderate acne. It works by reducing the amount of acne-causing bacteria on the skin and by helping to keep your pores open and unblocked, thus decreasing the number of acne pimples. Azelaic acid belongs to a class of drugs known as dicarboxylic acids.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020428
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-2007
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 54868-4442-0 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Azelex, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 30 billable units per package. 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 Physicians Total Care, Inc. on May 31, 2007. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat mild to moderate acne. It works by reducing the amount of acne-causing bacteria on the skin and by helping to keep your pores open and unblocked, thus decreasing the number of acne pimples. Azelaic acid belongs to a class of drugs known as dicarboxylic acids.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868444200. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 total billable units per package. 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 (5-4-1)
54868-4442-0
11-Digit CMS (5-4-2)
54868-4442-00

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