Ziprasidone Hydrochloride
NDC Package 64725-2168-1

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 Hydrochloride is capsules are indicated for the treatment of schizophrenia. Marketed by Tya Pharmaceuticals, this product is identified by NDC 64725-2168 and is authorized under FDA application ANDA077562.

Identification & Billing

NDC Package Code
64725-2168-1
Package Description
30 CAPSULE in 1 CONTAINER
Product Code
64725-2168
11-Digit Billing Format
64725216801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ziprasidone Hydrochloride
Dosage Form
-
Usage Information
Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. 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 ]. 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 ( ) 5.2WARNINGS AND PRECAUTIONS ( ) 5.2

Regulatory & Marketing

Labeler Name
Tya Pharmaceuticals
FDA Application #
ANDA077562
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2013
Listing Expiration
12-31-2017
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 64725-2168-1 identifies a specific commercial package of 30 capsule in 1 container of Ziprasidone Hydrochloride, labeled by Tya Pharmaceuticals. 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 Tya Pharmaceuticals on February 13, 2013. The current certification is valid through December 31, 2017.

How is this Tya Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64725216801. 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)
64725-2168-1
11-Digit CMS (5-4-2)
64725-2168-01

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