Ondansetron Tablet, Orally Disintegrating
NDC Package 83008-026-65

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Ondansetron tablets is a medication used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Quality Care Products, Llc, this product is identified by NDC 83008-026 and is authorized under FDA application ANDA078152.

Identification & Billing

NDC Package Code
83008-026-65
Package Description
30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
83008-026
11-Digit Billing Format
83008002665
RxNorm Crosswalk
RxCUI: 104894 - ondansetron 4 MG Disintegrating Oral Tablet

Clinical Specifications

Proprietary Name
Ondansetron
Non-Proprietary Name
Ondansetron
Substance Name
Ondansetron
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ONDANSETRON 4 mg/1
Pharmacologic Class
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. Ondansetron works by blocking one of the body's natural substances (serotonin) that causes vomiting.

Regulatory & Marketing

Labeler Name
Quality Care Products, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078152
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-12-2023
End Marketing Date
06-30-2026
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 (83008-026). Click a package code to view its specific billing and regulatory data.

83008-026-10
10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE

* 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 83008-026-65 identifies a specific commercial package of 30 tablet, orally disintegrating in 1 blister pack of Ondansetron, a human prescription drug labeled by Quality Care Products, Llc. This tablet, orally disintegrating is formulated for oral use and contains ondansetron 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 Quality Care Products, Llc on May 12, 2023.

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. Ondansetron works by blocking one of the body's natural substances (serotonin) that causes vomiting.

How is this Quality Care Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83008002665. 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)
83008-026-65
11-Digit CMS (5-4-2)
83008-0026-65

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