Ondansetron
NDC Package 50436-4091-1

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 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 abdomen.Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting. Marketed by Unit Dose Services, this product is identified by NDC 50436-4091 and is authorized under FDA application ANDA077009.

Identification & Billing

NDC Package Code
50436-4091-1
Package Description
72 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE
Product Code
50436-4091
11-Digit Billing Format
50436409101
RxNorm Crosswalk

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 abdomen.Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA077009
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2007
Listing Expiration
12-31-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50436-4091-1 identifies a specific commercial package of 72 cup, unit-dose in 1 case / 5 ml in 1 cup, unit-dose of Ondansetron, labeled by Unit Dose Services. 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 Unit Dose Services on November 30, 2007. The current certification is valid through December 31, 2020.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436409101. 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)
50436-4091-1
11-Digit CMS (5-4-2)
50436-4091-01

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