Erythromycin-benzoyl Peroxide
NDC Package 54868-5617-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Erythromycin-benzoyl Peroxide is a medication used to treat moderate acne. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5617 and is authorized under FDA application ANDA050557.

Identification & Billing

NDC Package Code
54868-5617-0
Package Description
23.3 g in 1 JAR
Product Code
54868-5617
11-Digit Billing Format
54868561700
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
23.3 GM
RxNorm Crosswalk
  • RxCUI: 244374 - erythromycin 3 % / benzoyl peroxide 5 % Topical Gel
  • RxCUI: 244374 - benzoyl peroxide 0.05 MG/MG / erythromycin 0.03 MG/MG Topical Gel
  • RxCUI: 244374 - benzoyl peroxide 5 % / erythromycin 3 % Topical Gel
  • RxCUI: 244374 - benzoyl peroxide 50 MG / erythromycin 30 MG per GM Topical Gel

Clinical Specifications

Proprietary Name
Erythromycin-benzoyl Peroxide
Dosage Form
-
Usage Information
This product is used to treat moderate acne. It helps to reduce the number of pimples. This medication is a combination of 2 drugs. Erythromycin works by stopping the growth of acne-causing bacteria. It belongs to a class of drugs known as macrolide antibiotics. Benzoyl peroxide also kills acne-causing bacteria and causes the top layer of skin to dry and peel off so that new skin can form. This product also contains alcohol which helps to dry extra oils from the skin.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA050557
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2008
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-5617-0 identifies a specific commercial package of 23.3 g in 1 jar of Erythromycin-benzoyl Peroxide, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 23.3 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 Physicians Total Care, Inc. on March 31, 2008. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This product is used to treat moderate acne. It helps to reduce the number of pimples. This medication is a combination of 2 drugs. Erythromycin works by stopping the growth of acne-causing bacteria. It belongs to a class of drugs known as macrolide antibiotics. Benzoyl peroxide also kills acne-causing bacteria and causes the top layer of skin to dry and peel off so that new skin can form. This product also contains alcohol which helps to dry extra oils from the skin.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868561700. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 23.3 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)
54868-5617-0
11-Digit CMS (5-4-2)
54868-5617-00

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