Ondansetron Tablet, Orally Disintegrating
NDC Package 60760-654-10

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

Package Information

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 St. Mary's Medical Park Pharmacy, this product is identified by NDC 60760-654 and is authorized under FDA application ANDA078152.

Identification & Billing

NDC Package Code
60760-654-10
Package Description
10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC
Product Code
60760-654
11-Digit Billing Format
60760065410
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
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
St. Mary's Medical Park Pharmacy
Product Type
Human Prescription Drug
FDA Application #
ANDA078152
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-22-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60760-654-10 identifies a specific commercial package of 10 tablet, orally disintegrating in 1 bottle, plastic of Ondansetron, a human prescription drug labeled by St. Mary's Medical Park Pharmacy. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. 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 St. Mary's Medical Park Pharmacy on December 22, 2022. The current certification is valid through December 31, 2026.

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 St. Mary's Medical Park Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60760065410. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. 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)
60760-654-10
11-Digit CMS (5-4-2)
60760-0654-10

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