Zuplenz
NDC Package 43288-104-10

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.

Zuplenz is a medication used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy), radiation treatment, or drugs used to put you to sleep before surgery. Marketed by Praelia Pharmaceuticals Inc, this product is identified by NDC 43288-104 and is authorized under FDA application NDA022524.

Identification & Billing

NDC Package Code
43288-104-10
Package Description
10 POUCH in 1 BOX / 1 FILM, SOLUBLE in 1 POUCH
Product Code
43288-104
11-Digit Billing Format
43288010410
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA

Clinical Specifications

Proprietary Name
Zuplenz
Dosage Form
-
Usage Information
This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy), radiation treatment, or drugs used to put you to sleep before surgery. Ondansetron works by blocking one of the body's natural substances (serotonin) that causes vomiting.

Regulatory & Marketing

Labeler Name
Praelia Pharmaceuticals Inc
FDA Application #
NDA022524
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-05-2010
End Marketing Date
11-30-2015
Listing Expiration
11-30-2015
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 43288-104-10 identifies a specific commercial package of 10 pouch in 1 box / 1 film, soluble in 1 pouch of Zuplenz, labeled by Praelia Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. 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 Praelia Pharmaceuticals Inc on July 05, 2010. The current certification is valid through November 30, 2015.

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), radiation treatment, or drugs used to put you to sleep before surgery. Ondansetron works by blocking one of the body's natural substances (serotonin) that causes vomiting.

How is this Praelia Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43288010410. 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)
43288-104-10
11-Digit CMS (5-4-2)
43288-0104-10

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