Ziprasidone
NDC Package 69189-2003-1

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 inactivated by the FDA.

Ziprasidone is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Marketed by Avera Mckennan Hospital, this product is identified by NDC 69189-2003 and is authorized under FDA application NDA020825.

Identification & Billing

NDC Package Code
69189-2003-1
Package Description
1 CAPSULE in 1 DOSE PACK
Product Code
69189-2003
11-Digit Billing Format
69189200301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ziprasidone
Dosage Form
-
Usage Information
Ziprasidone is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].

Regulatory & Marketing

Labeler Name
Avera Mckennan Hospital
FDA Application #
NDA020825
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-09-2016
Listing Expiration
12-31-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69189-2003-1 identifies a specific commercial package of 1 capsule in 1 dose pack of Ziprasidone, labeled by Avera Mckennan Hospital. 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 Avera Mckennan Hospital on February 09, 2016. The current certification is valid through December 31, 2018.

How is this Avera Mckennan Hospital product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69189200301. 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 (5-4-1)
69189-2003-1
11-Digit CMS (5-4-2)
69189-2003-01

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