Xifaxan Tablet
NDC Package 65649-301-41

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Xifaxan (rifaximin) tablets is a medication used to treat diarrhea caused by the common bacteria known as E. This formulation utilizes a tablet delivery system. Marketed by Salix Pharmaceuticals, Inc., this product is identified by NDC 65649-301 and is authorized under FDA application NDA021361.

Identification & Billing

NDC Package Code
65649-301-41
Package Description
100 TABLET in 1 BOTTLE
Product Code
65649-301
11-Digit Billing Format
65649030141
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xifaxan
Non-Proprietary Name
Rifaximin
Substance Name
Rifaximin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RIFAXIMIN 200 mg/1
Pharmacologic Class
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
Salix Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021361
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-25-2004
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65649-301). Click a package code to view its specific billing and regulatory data.

65649-301-03
30 TABLET in 1 BOTTLE
65649-301-05
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

* 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 65649-301-41 identifies a specific commercial package of 100 tablet in 1 bottle of Xifaxan, a human prescription drug labeled by Salix Pharmaceuticals, Inc.. This tablet is formulated for oral 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 Salix Pharmaceuticals, Inc. on July 25, 2004. The current certification is valid through December 31, 2027.

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 Salix Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65649030141. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
65649-301-41
11-Digit CMS (5-4-2)
65649-0301-41

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