Lurasidone Hcl Powder
NDC Package 65862-950-37

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Lurasidone Hcl powders is a medication used to treat certain mental/mood disorders (such as schizophrenia, depression associated with bipolar disorder). This formulation utilizes a powder delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-950.

Identification & Billing

NDC Package Code
65862-950-37
Package Description
50 kg in 1 DRUM
Product Code
65862-950
11-Digit Billing Format
65862095037

Clinical Specifications

Proprietary Name
Lurasidone Hcl
Non-Proprietary Name
Lurasidone Hcl
Substance Name
Lurasidone Hydrochloride
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
LURASIDONE HYDROCHLORIDE 50 kg/50kg
Usage Information
This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression associated with bipolar disorder). Lurasidone helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Lurasidone is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-11-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65862-950-37 identifies a specific commercial package of 50 kg in 1 drum of Lurasidone Hcl (UNFINISHED drug), a bulk ingredient labeled by Aurobindo Pharma Limited. This powder is formulated for use and contains lurasidone 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 Aurobindo Pharma Limited on January 11, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression associated with bipolar disorder). Lurasidone helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Lurasidone is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862095037. 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)
65862-950-37
11-Digit CMS (5-4-2)
65862-0950-37

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