Rifaximin Powder
NDC Package 59285-008-01

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 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.

Rifaximin powders is a medication used to treat diarrhea caused by the common bacteria known as E. This formulation utilizes a powder delivery system. Marketed by Optimus Drugs Private Limited, this product is identified by NDC 59285-008.

Identification & Billing

NDC Package Code
59285-008-01
Package Description
25 kg in 1 DRUM
Product Code
59285-008
11-Digit Billing Format
59285000801

Clinical Specifications

Proprietary Name
Rifaximin
Non-Proprietary Name
Rifaximin
Substance Name
Rifaximin
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)
RIFAXIMIN 1 kg/kg
Usage Information
This medication is used to treat diarrhea caused by the common bacteria known as E. coli ("traveler's diarrhea"). Rifaximin should not be used if you have a fever or bloody diarrhea. 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. Rifaximin is also used to treat irritable bowel syndrome with diarrhea. It is also used to prevent a brain problem caused by liver disease (hepatic encephalopathy). It may help you think more clearly.

Regulatory & Marketing

Labeler Name
Optimus Drugs Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-11-2015
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 59285-008-01 identifies a specific commercial package of 25 kg in 1 drum of Rifaximin (UNFINISHED drug), a bulk ingredient labeled by Optimus Drugs Private Limited. This powder is formulated for use and contains rifaximin 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 Optimus Drugs Private Limited on May 11, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat diarrhea caused by the common bacteria known as E. coli ("traveler's diarrhea"). Rifaximin should not be used if you have a fever or bloody diarrhea. 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. Rifaximin is also used to treat irritable bowel syndrome with diarrhea. It is also used to prevent a brain problem caused by liver disease (hepatic encephalopathy). It may help you think more clearly.

How is this Optimus Drugs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59285000801. 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)
59285-008-01
11-Digit CMS (5-4-2)
59285-0008-01

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