Minocin
NDC Package 54531-100-01

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 discontinued by the firm.

Minocin is minocycline is used to treat a wide variety of infections. Marketed by Rempex Pharmaceuticals, Inc, this product is identified by NDC 54531-100 and is authorized under FDA application NDA050444.

Identification & Billing

NDC Package Code
54531-100-01
Package Description
10 INJECTION in 1 CARTON
Product Code
54531-100
11-Digit Billing Format
54531010001

Clinical Specifications

Proprietary Name
Minocin
Dosage Form
-
Usage Information
Minocycline is used to treat a wide variety of infections. This medication belongs to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Rempex Pharmaceuticals, Inc
FDA Application #
NDA050444
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-19-2013
End Marketing Date
12-31-2016
Listing Expiration
12-31-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54531-100-01 identifies a specific commercial package of 10 injection in 1 carton of Minocin, labeled by Rempex 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 Rempex Pharmaceuticals, Inc on April 19, 2013. The current certification is valid through December 31, 2016.

What are the primary indications for this medication?

Minocycline is used to treat a wide variety of infections. This medication belongs to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54531010001. 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)
54531-100-01
11-Digit CMS (5-4-2)
54531-0100-01

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