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  5. NDC Package Code: 16110-869-50 Azelex

NDC Package 16110-869-50 Azelex

Azelaic Acid Cream Cutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
16110-869-50
Package Description:
1 TUBE in 1 CARTON / 50 g in 1 TUBE
Product Code:
16110-869
Proprietary Name:
Azelex
Non-Proprietary Name:
Azelaic Acid
Substance Name:
Azelaic Acid
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.
11-Digit NDC Billing Format:
16110086950
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
50 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 1041520 - azelaic acid 20 % Topical Cream
  • RxCUI: 1041520 - azelaic acid 200 MG/ML Topical Cream
  • RxCUI: 1043753 - Azelex 20 % Topical Cream
  • RxCUI: 1043753 - azelaic acid 200 MG/ML Topical Cream [Azelex]
  • RxCUI: 1043753 - Azelex 200 MG/ML Topical Cream
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Almirall, Llc
    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(s):
  • Cutaneous - Administration to the skin.
    • Active Ingredient(s):
  • AZELAIC ACID .2 g/g
    • Pharmacologic Class(es):
  • Decreased Protein Synthesis - [PE] (Physiologic Effect)
  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    NDA020428
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-24-2018
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    16110-869-301 TUBE in 1 CARTON / 30 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 16110-869-50?

    The NDC Packaged Code 16110-869-50 is assigned to a package of 1 tube in 1 carton / 50 g in 1 tube of Azelex, a human prescription drug labeled by Almirall, Llc. The product's dosage form is cream and is administered via cutaneous form.This product is billed per "GM" gram and contains an estimated amount of 50 billable units per package.

    Is NDC 16110-869 included in the NDC Directory?

    Yes, Azelex with product code 16110-869 is active and included in the NDC Directory. The product was first marketed by Almirall, Llc on September 24, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 16110-869-50?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 50.

    What is the 11-digit format for NDC 16110-869-50?

    The 11-digit format is 16110086950. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-216110-869-505-4-216110-0869-50