Azelaic Acid Gel
NDC Package 0591-2131-55

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Azelaic Acid gel is a medication used to treat a certain skin condition called rosacea. This formulation utilizes a gel delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2131 and is authorized under FDA application ANDA208011.

Identification & Billing

NDC Package Code
0591-2131-55
Package Description
1 TUBE in 1 CARTON / 50 g in 1 TUBE
Product Code
0591-2131
11-Digit Billing Format
00591213155
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azelaic Acid
Non-Proprietary Name
Azelaic Acid
Substance Name
Azelaic Acid
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
AZELAIC ACID .15 g/g
Pharmacologic Class
Usage Information
This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208011
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-19-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 0591-2131-55 identifies a specific commercial package of 1 tube in 1 carton / 50 g in 1 tube of Azelaic Acid, a human prescription drug labeled by Actavis Pharma, Inc.. This gel is formulated for topical use and contains azelaic acid as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Actavis Pharma, Inc. on November 19, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591213155. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 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 (4-4-2)
0591-2131-55
11-Digit CMS (5-4-2)
00591-2131-55

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