Azelex Cream
NDC Package 16110-869-50

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

Azelex (azelaic acid) cream is a medication used to treat mild to moderate acne. This formulation utilizes a cream delivery system. Marketed by Almirall, Llc, this product is identified by NDC 16110-869 and is authorized under FDA application NDA020428.

Identification & Billing

NDC Package Code
16110-869-50
Package Description
1 TUBE in 1 CARTON / 50 g in 1 TUBE
Product Code
16110-869
11-Digit Billing Format
16110086950
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
Azelex
Non-Proprietary Name
Azelaic Acid
Substance Name
Azelaic Acid
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
AZELAIC ACID .2 g/g
Pharmacologic Class
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
Almirall, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020428
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-24-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16110-869). Click a package code to view its specific billing and regulatory data.

16110-869-30
1 TUBE in 1 CARTON / 30 g 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 16110-869-50 identifies a specific commercial package of 1 tube in 1 carton / 50 g in 1 tube of Azelex, a human prescription drug labeled by Almirall, Llc. This product is billed per "GM" gram and contains an estimated amount of 50 billable units per package. This cream is formulated for cutaneous 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 Almirall, Llc on September 24, 2018. The current certification is valid through December 31, 2026.

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 Almirall, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16110086950. 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 (5-3-2)
16110-869-50
11-Digit CMS (5-4-2)
16110-0869-50

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