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  5. NDC Package Code: 0480-2596-34 Fidaxomicin

NDC Package 0480-2596-34 Fidaxomicin

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0480-2596-34
Package Description:
20 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0480-2596
Proprietary Name:
Fidaxomicin
Non-Proprietary Name:
Fidaxomicin
Substance Name:
Fidaxomicin
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.
11-Digit NDC Billing Format:
00480259634
NDC to RxNorm Crosswalk:
RxCUI: 1111106 - fidaxomicin 200 MG Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Teva Pharmaceuticals, Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
FIDAXOMICIN 200 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA208443
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-15-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 0480-2596-34?

The NDC Packaged Code 0480-2596-34 is assigned to a package of 20 tablet, film coated in 1 bottle of Fidaxomicin, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0480-2596 included in the NDC Directory?

Yes, Fidaxomicin with product code 0480-2596 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals, Inc. on July 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0480-2596-34?

The 11-digit format is 00480259634. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20480-2596-345-4-200480-2596-34