Ondansetron
NDC Package 63304-347-69

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 1. Marketed by Rnabaxy Pharmaceuticals Inc., this product is identified by NDC 63304-347 and is authorized under FDA application ANDA078602.

Identification & Billing

NDC Package Code
63304-347-69
Package Description
1 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63304-347-11)
Product Code
63304-347
11-Digit Billing Format
63304034769
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ondansetron
Dosage Form
-
Usage Information
1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2. 2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.

Regulatory & Marketing

Labeler Name
Rnabaxy Pharmaceuticals Inc.
FDA Application #
ANDA078602
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-10-2012
Listing Expiration
12-31-2019
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 (63304-347). Click a package code to view its specific billing and regulatory data.

63304-347-05
500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
63304-347-30
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

* 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 63304-347-69 identifies a specific commercial package of 1 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack (63304-347-11) of Ondansetron, labeled by Rnabaxy 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 Rnabaxy Pharmaceuticals Inc. on January 10, 2012. The current certification is valid through December 31, 2019.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304034769. 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)
63304-347-69
11-Digit CMS (5-4-2)
63304-0347-69

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