Adapalene Gel
NDC Package 21130-708-05

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

Package Information

Adapalene gel is a medication used to treat acne. This formulation utilizes a gel delivery system. Marketed by Safeway, Inc., this product is identified by NDC 21130-708 and is authorized under FDA application ANDA091314.

Identification & Billing

NDC Package Code
21130-708-05
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE
Product Code
21130-708
11-Digit Billing Format
21130070805
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Adapalene
Non-Proprietary Name
Adapalene
Substance Name
Adapalene
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)
ADAPALENE 1 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

Regulatory & Marketing

Labeler Name
Safeway, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA091314
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-30-2019
End Marketing Date
03-30-2027
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 21130-708-05 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube of Adapalene, a human over the counter drug labeled by Safeway, Inc.. This gel is formulated for topical use and contains adapalene 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 Safeway, Inc. on August 30, 2019.

What are the primary indications for this medication?

This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130070805. 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)
21130-708-05
11-Digit CMS (5-4-2)
21130-0708-05

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