Adapalene And Benzoyl Peroxide Gel
NDC Package 63629-8607-1

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

Package Information

Adapalene And Benzoyl Peroxide gel is 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. This formulation utilizes a gel delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-8607 and is authorized under FDA application ANDA205033.

Identification & Billing

NDC Package Code
63629-8607-1
Package Description
1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP
Product Code
63629-8607
11-Digit Billing Format
63629860701
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM
RxNorm Crosswalk
  • RxCUI: 829539 - adapalene 0.1 % / benzoyl peroxide 2.5 % Topical Gel
  • RxCUI: 829539 - adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Adapalene And Benzoyl Peroxide
Non-Proprietary Name
Adapalene And Benzoyl Peroxide
Substance Name
Adapalene; Benzoyl Peroxide
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)
Pharmacologic Class
Usage Information
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA205033
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-24-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63629-8607-1 identifies a specific commercial package of 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump of Adapalene And Benzoyl Peroxide, a human prescription drug labeled by Bryant Ranch Prepack. This product is billed per "GM" gram and contains an estimated amount of 45 billable units per package. This gel is formulated for topical use and contains adapalene; benzoyl peroxide 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 Bryant Ranch Prepack on January 24, 2018. The current certification is valid through December 31, 2026.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629860701. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 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 (5-4-1)
63629-8607-1
11-Digit CMS (5-4-2)
63629-8607-01

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