Benzoyl Peroxide Gel
NDC Package 47643-003-04

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Benzoyl Peroxide gel is a medication used to treat mild to moderate acne. This formulation utilizes a gel delivery system. Marketed by Vantage Specialty Ingredients, Inc., this product is identified by NDC 47643-003.

Identification & Billing

NDC Package Code
47643-003-04
Package Description
18.15 kg in 1 PAIL
Product Code
47643-003
11-Digit Billing Format
47643000304

Clinical Specifications

Proprietary Name
Benzoyl Peroxide
Non-Proprietary Name
Benzoyl Peroxide
Substance Name
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.
Active Ingredient(s)
BENZOYL PEROXIDE .4 kg/kg
Usage Information
This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Vantage Specialty Ingredients, Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-15-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (47643-003). Click a package code to view its specific billing and regulatory data.

47643-003-50
226.8 kg in 1 DRUM

* 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 47643-003-04 identifies a specific commercial package of 18.15 kg in 1 pail of Benzoyl Peroxide (UNFINISHED drug), drug for further processing labeled by Vantage Specialty Ingredients, Inc.. This gel is formulated for use and contains 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 Vantage Specialty Ingredients, Inc. on May 15, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Vantage Specialty Ingredients, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47643000304. 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)
47643-003-04
11-Digit CMS (5-4-2)
47643-0003-04

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