Ziprasidone Mesylate Injection, Powder, Lyophilized, For Solution
NDC Package 82449-004-01

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 Mesylate injection is ziprasidone injection is used to treat occurrences of severe agitation in patients with schizophrenia. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Steriscience Specialties Private Limited, this product is identified by NDC 82449-004 and is authorized under FDA application ANDA217595.

Identification & Billing

NDC Package Code
82449-004-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
82449-004
11-Digit Billing Format
82449000401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ziprasidone Mesylate
Non-Proprietary Name
Ziprasidone Mesylate
Substance Name
Ziprasidone Mesylate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
ZIPRASIDONE MESYLATE 20 mg/mL
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Ziprasidone injection is used to treat occurrences of severe agitation in patients with schizophrenia. It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Ziprasidone injection is used when quick relief of your symptoms is required. It is not used together with the form of this medication that is taken by mouth. An injection of ziprasidone works quickly to reduce tension and anxiety which, if untreated, can result in dangerous behavior and interfere with your treatment and care.

Regulatory & Marketing

Labeler Name
Steriscience Specialties Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217595
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-19-2025
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 (82449-004). Click a package code to view its specific billing and regulatory data.

82449-004-02
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

* 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 82449-004-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Ziprasidone Mesylate, a human prescription drug labeled by Steriscience Specialties Private Limited. This injection, powder, lyophilized, for solution is formulated for intramuscular use and contains ziprasidone mesylate 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 Steriscience Specialties Private Limited on December 19, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ziprasidone injection is used to treat occurrences of severe agitation in patients with schizophrenia. It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Ziprasidone injection is used when quick relief of your symptoms is required. It is not used together with the form of this medication that is taken by mouth. An injection of ziprasidone works quickly to reduce tension and anxiety which, if untreated, can result in dangerous behavior and interfere with your treatment and care.

How is this Steriscience Specialties Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82449000401. 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)
82449-004-01
11-Digit CMS (5-4-2)
82449-0004-01

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