Fidaxomicin Tablet, Film Coated
NDC Package 0480-2596-34

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

Package Information

Fidaxomicin tablets is a medication used to treat a severe intestinal condition (C. This formulation utilizes a tablet, film coated delivery system. Marketed by Teva Pharmaceuticals, Inc., this product is identified by NDC 0480-2596 and is authorized under FDA application ANDA208443.

Identification & Billing

NDC Package Code
0480-2596-34
Package Description
20 TABLET, FILM COATED in 1 BOTTLE
Product Code
0480-2596
11-Digit Billing Format
00480259634
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
20 EA
RxNorm Crosswalk
RxCUI: 1111106 - fidaxomicin 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Fidaxomicin
Non-Proprietary Name
Fidaxomicin
Substance Name
Fidaxomicin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FIDAXOMICIN 200 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a severe intestinal condition (C. difficile-associated diarrhea) due to a certain type of bacteria. This condition may rarely occur after taking antibiotics. Symptoms include diarrhea that doesn't stop, stomach/abdominal pain or cramping, and blood/mucus in your stool. Fidaxomicin is known as a macrolide antibiotic. It works by stopping the growth of this bacteria. This antibiotic works in the intestines and is not absorbed by your body. It should only be used to treat this type of intestinal bacterial infection. It will not work for other types of infections, including viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208443
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2025
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0480-2596-34 identifies a specific commercial package of 20 tablet, film coated in 1 bottle of Fidaxomicin, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains fidaxomicin 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 Teva Pharmaceuticals, Inc. on July 15, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a severe intestinal condition (C. difficile-associated diarrhea) due to a certain type of bacteria. This condition may rarely occur after taking antibiotics. Symptoms include diarrhea that doesn't stop, stomach/abdominal pain or cramping, and blood/mucus in your stool. Fidaxomicin is known as a macrolide antibiotic. It works by stopping the growth of this bacteria. This antibiotic works in the intestines and is not absorbed by your body. It should only be used to treat this type of intestinal bacterial infection. It will not work for other types of infections, including viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00480259634. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 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 (4-4-2)
0480-2596-34
11-Digit CMS (5-4-2)
00480-2596-34

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