Fidaxomicin Tablet, Coated
NDC Package 0054-0795-07

11-digit billing NDC: 00054079507
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, coated delivery system. Marketed by Hikma Pharmceuticals Usa Inc., this product is identified by NDC 0054-0795 and is authorized under FDA application ANDA219737.

Identification & Billing

NDC Package Code
0054-0795-07
Package Description
20 TABLET, COATED in 1 BOTTLE
Product Code
0054-0795
11-Digit Billing Format
00054079507

Clinical Specifications

Proprietary Name
Fidaxomicin
Non-Proprietary Name
Fidaxomicin
Substance Name
Fidaxomicin
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
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
Hikma Pharmceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA219737
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0054-0795-07 identifies a specific commercial package of 20 tablet, coated in 1 bottle of Fidaxomicin, a human prescription drug labeled by Hikma Pharmceuticals Usa Inc.. This tablet, 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 Hikma Pharmceuticals Usa Inc. on October 07, 2026. The current certification is valid through December 31, 2027.

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 Hikma Pharmceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054079507. 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)
0054-0795-07
11-Digit CMS (5-4-2)
00054-0795-07

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