NDC Package 43538-320-30 Xepi

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

43538-320-30

Package Description:

1 TUBE in 1 BOX / 30 g in 1 TUBE

Product Code:

43538-320

Proprietary Name:

Xepi

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.

11-Digit NDC Billing Format:

43538032030

Labeler Name:

Medimetriks Pharmaceuticals, Inc.

Sample Package:

FDA Application Number:

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 Date:

02-02-2018

Exclude Flag:

Code Structure:

43538 - Medimetriks Pharmaceuticals, Inc.
- 43538-320 - Xepi
  - 43538-320-30 - 1 TUBE in 1 BOX / 30 g in 1 TUBE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
43538-320-10	1 TUBE in 1 BOX / 10 g in 1 TUBE
43538-320-45	1 TUBE in 1 BOX / 45 g in 1 TUBE
43538-320-99	4 TUBE in 1 BOX / 3 g in 1 TUBE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 43538-320-30?

The NDC Packaged Code 43538-320-30 is assigned to a package of 1 tube in 1 box / 30 g in 1 tube of Xepi, labeled by Medimetriks Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 43538-320 included in the NDC Directory?

No, Xepi with product code 43538-320 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Medimetriks Pharmaceuticals, Inc. on December 15, 2017 and its listing in the NDC Directory is set to expire on February 02, 2018 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 43538-320-30?

The 11-digit format is 43538032030. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	43538-320-30	5-4-2	43538-0320-30

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