Doxycycline Hyclate Powder
NDC Package 60592-201-10

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 powders is a medication used to treat a wide variety of bacterial infections, including those that cause acne. This formulation utilizes a powder delivery system. Marketed by Kalchem International Inc, this product is identified by NDC 60592-201.

Identification & Billing

NDC Package Code
60592-201-10
Package Description
1 g in 1 BOTTLE
Product Code
60592-201
11-Digit Billing Format
60592020110
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
1 GM

Clinical Specifications

Proprietary Name
Doxycycline Hyclate
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Hyclate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 1 g/g
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
Kalchem International Inc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
11-29-2019
Listing Expiration
12-31-2026
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 60592-201-10 identifies a specific commercial package of 1 g in 1 bottle of Doxycycline Hyclate (UNFINISHED drug), a bulk ingredient labeled by Kalchem International Inc. This product is billed per "GM" gram and contains an estimated amount of 1 billable units per package. This powder 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 Kalchem International Inc on November 29, 2019. The current certification is valid through December 31, 2026.

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 Kalchem International Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60592020110. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 1 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 (5-3-2)
60592-201-10
11-Digit CMS (5-4-2)
60592-0201-10

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