Nitazoxanide Tablet, Film Coated
NDC Package 64980-526-03

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

Nitazoxanide tablets is a medication used to treat diarrhea caused by certain parasite infections of the intestines (Cryptosporidium parvum and Giardia lamblia). This formulation utilizes a tablet, film coated delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 64980-526 and is authorized under FDA application ANDA213820.

Identification & Billing

NDC Package Code
64980-526-03
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
64980-526
11-Digit Billing Format
64980052603
RxNorm Crosswalk
RxCUI: 427163 - nitazoxanide 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Nitazoxanide
Non-Proprietary Name
Nitazoxanide
Substance Name
Nitazoxanide
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)
NITAZOXANIDE 500 mg/1
Pharmacologic Class
Antiprotozoal - [EPC] (Established Pharmacologic Class)
Usage Information
This medication is used to treat diarrhea caused by certain parasite infections of the intestines (Cryptosporidium parvum and Giardia lamblia).

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213820
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-27-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64980-526). Click a package code to view its specific billing and regulatory data.

64980-526-21
12 TABLET, FILM COATED in 1 BOTTLE
64980-526-60
6 TABLET, FILM COATED in 1 BOTTLE
64980-526-81
18 TABLET, FILM COATED in 1 BOTTLE

* 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 64980-526-03 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Nitazoxanide, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This tablet, film coated is formulated for oral use and contains nitazoxanide 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 Rising Pharma Holdings, Inc. on November 27, 2020. 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 certain parasite infections of the intestines (Cryptosporidium parvum and Giardia lamblia).

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64980052603. 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)
64980-526-03
11-Digit CMS (5-4-2)
64980-0526-03

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