Zuplenz
NDC Package 57881-444-01

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 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 Galena Biopharma, Inc., this product is identified by NDC 57881-444 and is authorized under FDA application NDA022524.

Identification & Billing

NDC Package Code
57881-444-01
Package Description
1 POUCH in 1 BOX / 1 FILM, SOLUBLE in 1 POUCH
Product Code
57881-444
11-Digit Billing Format
57881044401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 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
Galena Biopharma, Inc.
FDA Application #
NDA022524
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-08-2014
End Marketing Date
08-01-2018
Listing Expiration
08-01-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57881-444). Click a package code to view its specific billing and regulatory data.

57881-444-10
10 POUCH in 1 BOX / 1 FILM, SOLUBLE in 1 POUCH

* 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 57881-444-01 identifies a specific commercial package of 1 pouch in 1 box / 1 film, soluble in 1 pouch of Zuplenz, labeled by Galena Biopharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Galena Biopharma, Inc. on October 08, 2014. The current certification is valid through August 01, 2018.

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 Galena Biopharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57881044401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
57881-444-01
11-Digit CMS (5-4-2)
57881-0444-01

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