Xepi
NDC Package 43538-320-99

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Xepi is ozenoxacin is used to treat a certain skin infection (impetigo). Marketed by Medimetriks Pharmaceuticals, Inc., this product is identified by NDC 43538-320 and is authorized under FDA application NDA208945.

Identification & Billing

NDC Package Code
43538-320-99
Package Description
4 TUBE in 1 BOX / 3 g in 1 TUBE
Product Code
43538-320
11-Digit Billing Format
43538032099

Clinical Specifications

Proprietary Name
Xepi
Dosage Form
-
Usage Information
Ozenoxacin is used to treat a certain skin infection (impetigo). This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of certain bacteria.

Regulatory & Marketing

Labeler Name
Medimetriks Pharmaceuticals, Inc.
FDA Application #
NDA208945
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-15-2017
End Marketing Date
02-02-2018
Listing Expiration
02-02-2018
Exclude Flag
D
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 (43538-320). Click a package code to view its specific billing and regulatory data.

43538-320-10
1 TUBE in 1 BOX / 10 g in 1 TUBE
43538-320-30
1 TUBE in 1 BOX / 30 g in 1 TUBE
43538-320-45
1 TUBE in 1 BOX / 45 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 43538-320-99 identifies a specific commercial package of 4 tube in 1 box / 3 g in 1 tube of Xepi, labeled by Medimetriks Pharmaceuticals, Inc.. 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 Medimetriks Pharmaceuticals, Inc. on December 15, 2017. The current certification is valid through February 02, 2018.

What are the primary indications for this medication?

Ozenoxacin is used to treat a certain skin infection (impetigo). This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of certain bacteria.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43538032099. 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)
43538-320-99
11-Digit CMS (5-4-2)
43538-0320-99

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