Aczone
NDC Package 16110-367-90

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 discontinued by the firm.

Aczone is a medication used to treat acne. Marketed by Almirall, Llc, this product is identified by NDC 16110-367 and is authorized under FDA application NDA021794.

Identification & Billing

NDC Package Code
16110-367-90
Package Description
1 TUBE in 1 CARTON / 90 g in 1 TUBE
Product Code
16110-367
11-Digit Billing Format
16110036790
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
90 GM

Clinical Specifications

Proprietary Name
Aczone
Dosage Form
-
Usage Information
This medication is used to treat acne. It helps decrease the number and severity of acne pimples and helps pimples that do develop to heal more quickly. Dapsone is an antibiotic. It is not known how dapsone works to treat acne.

Regulatory & Marketing

Labeler Name
Almirall, Llc
FDA Application #
NDA021794
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-12-2021
End Marketing Date
07-31-2025
Listing Expiration
07-31-2025
Exclude Flag
D
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 (16110-367). Click a package code to view its specific billing and regulatory data.

16110-367-60
1 TUBE in 1 CARTON / 60 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 16110-367-90 identifies a specific commercial package of 1 tube in 1 carton / 90 g in 1 tube of Aczone, labeled by Almirall, Llc. This product is billed per "GM" gram and contains an estimated amount of 90 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 Almirall, Llc on February 12, 2021. The current certification is valid through July 31, 2025.

What are the primary indications for this medication?

This medication is used to treat acne. It helps decrease the number and severity of acne pimples and helps pimples that do develop to heal more quickly. Dapsone is an antibiotic. It is not known how dapsone works to treat acne.

How is this Almirall, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16110036790. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 90 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)
16110-367-90
11-Digit CMS (5-4-2)
16110-0367-90

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