Ziprasidone Capsule
NDC Package 55111-259-01

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

Ziprasidone capsules is ziprasidone hydrochloride capsules are 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. This formulation utilizes a capsule delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-259 and is authorized under FDA application ANDA077565.

Identification & Billing

NDC Package Code
55111-259-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
55111-259
11-Digit Billing Format
55111025901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ziprasidone
Non-Proprietary Name
Ziprasidone
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, 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 (5.3)]. 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 (5.3)]Schizophrenia Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)]Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone hydrochloride capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone hydrochloride capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA077565
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-02-2012
Listing Expiration
12-31-2027
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 (55111-259). Click a package code to view its specific billing and regulatory data.

55111-259-05
500 CAPSULE in 1 BOTTLE
55111-259-30
30 CAPSULE in 1 BOTTLE
55111-259-60
60 CAPSULE in 1 BOTTLE
55111-259-78
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
55111-259-81
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
55111-259-90
90 CAPSULE in 1 BOTTLE

* 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 55111-259-01 identifies a specific commercial package of 100 capsule in 1 bottle of Ziprasidone, a human prescription drug labeled by Dr. Reddy's Laboratories 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 Dr. Reddy's Laboratories Limited on March 02, 2012. The current certification is valid through December 31, 2027.

How is this Dr. Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111025901. 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)
55111-259-01
11-Digit CMS (5-4-2)
55111-0259-01

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