Adapalene Paraben Free Gel
NDC Package 0363-5483-16

11-digit billing NDC: 00363548316
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Adapalene Paraben Free (adapalene) gel is adults and children 12 years of age and older:use once dailyclean the skin gently and pat dry before applying the productcover the entire affected area with a thin layer. This formulation utilizes a gel delivery system. Marketed by Walgreens, this product is identified by NDC 0363-5483 and is authorized under FDA application ANDA090962.

Identification & Billing

NDC Package Code
0363-5483-16
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
0363-5483
11-Digit Billing Format
00363548316

Clinical Specifications

Proprietary Name
Adapalene Paraben Free
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
Adults and children 12 years of age and older:use once dailyclean the skin gently and pat dry before applying the productcover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.Children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Walgreens
Product Type
Human Otc Drug
FDA Application #
ANDA090962
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2026
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0363-5483). Click a package code to view its specific billing and regulatory data.

0363-5483-05
1 TUBE in 1 CARTON / 15 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 0363-5483-16 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Adapalene Paraben Free, a human over the counter drug labeled by Walgreens. 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 Walgreens on November 01, 2026. The current certification is valid through December 31, 2027.

How is this Walgreens product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363548316. 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)
0363-5483-16
11-Digit CMS (5-4-2)
00363-5483-16

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