Ondansetron
NDC Package 53002-0580-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ondansetron is indicated for the prevention of nausea and vomiting associated with:•highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2•initial and repeat courses of moderately emetogenic cancer chemotherapy•radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomenOndansetron is also indicated for the prevention of postoperative nausea and/or vomiting. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-0580 and is authorized under FDA application ANDA078152.

Identification & Billing

NDC Package Code
53002-0580-2
Package Description
6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
53002-0580
11-Digit Billing Format
53002058002
RxNorm Crosswalk
RxCUI: 104894 - ondansetron 4 MG Disintegrating Oral Tablet

Clinical Specifications

Proprietary Name
Ondansetron
Dosage Form
-
Usage Information
Ondansetron is indicated for the prevention of nausea and vomiting associated with:•highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2•initial and repeat courses of moderately emetogenic cancer chemotherapy•radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomenOndansetron is also indicated for the prevention of postoperative nausea and/or vomiting.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA078152
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2007
Listing Expiration
12-31-2024
Exclude Flag
I
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 (53002-0580). Click a package code to view its specific billing and regulatory data.

53002-0580-1
3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
53002-0580-3
10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
53002-0580-4
30 TABLET, ORALLY DISINTEGRATING 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 53002-0580-2 identifies a specific commercial package of 6 tablet, orally disintegrating in 1 blister pack of Ondansetron, labeled by Rpk Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rpk Pharmaceuticals, Inc. on June 27, 2007. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002058002. 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 (5-4-1)
53002-0580-2
11-Digit CMS (5-4-2)
53002-0580-02

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