Risperidone
NDC Package 65841-641-06

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 discontinued by the firm.

Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-641 and is authorized under FDA application ANDA078516.

Identification & Billing

NDC Package Code
65841-641-06
Package Description
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
65841-641
11-Digit Billing Format
65841064106

Clinical Specifications

Proprietary Name
Risperidone
Dosage Form
-
Usage Information
Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life. Risperidone belongs to a 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
Zydus Lifesciences Limited
FDA Application #
ANDA078516
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-29-2010
End Marketing Date
05-12-2025
Listing Expiration
05-12-2025
Exclude Flag
D
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 65841-641-06 identifies a specific commercial package of 30 tablet, orally disintegrating in 1 bottle of Risperidone, labeled by Zydus Lifesciences Limited. 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 Zydus Lifesciences Limited on June 29, 2010. The current certification is valid through May 12, 2025.

What are the primary indications for this medication?

Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life. Risperidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

How is this Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841064106. 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)
65841-641-06
11-Digit CMS (5-4-2)
65841-0641-06

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