Doxycycline Hyclate Tablet, Delayed Release
NDC Package 50546-560-99

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 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.

Doxycycline Hyclate tablets is a medication used to treat a wide variety of bacterial infections, including those that cause acne. This formulation utilizes a tablet, delayed release delivery system. Marketed by Mayne Pharma International Pty Ltd., this product is identified by NDC 50546-560.

Identification & Billing

NDC Package Code
50546-560-99
Package Description
1 BAG in 1 DRUM / 1346517 TABLET, DELAYED RELEASE in 1 BAG
Product Code
50546-560
11-Digit Billing Format
50546056099

Clinical Specifications

Proprietary Name
Doxycycline Hyclate
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Hyclate
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 60 mg/1
Usage Information
This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. 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
Mayne Pharma International Pty Ltd.
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
06-30-2022
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50546-560-99 identifies a specific commercial package of 1 bag in 1 drum / 1346517 tablet, delayed release in 1 bag of Doxycycline Hyclate (UNFINISHED drug), drug for further processing labeled by Mayne Pharma International Pty Ltd.. This tablet, delayed release is formulated for use and contains doxycycline hyclate 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 Mayne Pharma International Pty Ltd. on June 30, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. 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 Mayne Pharma International Pty Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50546056099. 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)
50546-560-99
11-Digit CMS (5-4-2)
50546-0560-99

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