Ziprasidone Hydrochloride Capsule
NDC Package 33342-147-51

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

Ziprasidone Hydrochloride capsules are indicated for the treatment of schizophrenia. This formulation utilizes a capsule delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-147 and is authorized under FDA application ANDA204375.

Identification & Billing

NDC Package Code
33342-147-51
Package Description
300 CAPSULE in 1 BOTTLE
Product Code
33342-147
11-Digit Billing Format
33342014751
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ziprasidone Hydrochloride
Non-Proprietary Name
Ziprasidone Hydrochloride
Substance Name
Ziprasidone Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZIPRASIDONE HYDROCHLORIDE 80 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
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 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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204375
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-18-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 (33342-147). Click a package code to view its specific billing and regulatory data.

33342-147-09
60 CAPSULE in 1 BOTTLE
33342-147-12
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

* 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 33342-147-51 identifies a specific commercial package of 300 capsule in 1 bottle of Ziprasidone Hydrochloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This capsule is formulated for oral use and contains ziprasidone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Macleods Pharmaceuticals Limited on February 18, 2017. The current certification is valid through December 31, 2026.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342014751. 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)
33342-147-51
11-Digit CMS (5-4-2)
33342-0147-51

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