Ondansetron Hcl
NDC Package 51655-400-43

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ondansetron Hcl is a medication used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy. Marketed by Northwind Pharmaceuticals, this product is identified by NDC 51655-400 and is authorized under FDA application ANDA077851.

Identification & Billing

NDC Package Code
51655-400-43
Package Description
3 TABLET, FILM COATED in 1 BOTTLE
Product Code
51655-400
11-Digit Billing Format
51655040043

Clinical Specifications

Proprietary Name
Ondansetron Hcl
Dosage Form
-
Usage Information
This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy. It is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body's natural substances (serotonin) that causes vomiting.

Regulatory & Marketing

Labeler Name
Northwind Pharmaceuticals
FDA Application #
ANDA077851
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-17-2014
End Marketing Date
12-31-2019
Listing Expiration
12-31-2019
Exclude Flag
D
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 51655-400-43 identifies a specific commercial package of 3 tablet, film coated in 1 bottle of Ondansetron Hcl, labeled by Northwind Pharmaceuticals. 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 Northwind Pharmaceuticals on March 17, 2014. The current certification is valid through December 31, 2019.

What are the primary indications for this medication?

This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy. It is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body's natural substances (serotonin) that causes vomiting.

How is this Northwind Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51655040043. 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)
51655-400-43
11-Digit CMS (5-4-2)
51655-0400-43

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