Risperidone
NDC Package 64679-554-01

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

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 Wockhardt Usa Llc., this product is identified by NDC 64679-554 and is authorized under FDA application ANDA078871.

Identification & Billing

NDC Package Code
64679-554-01
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
64679-554
11-Digit Billing Format
64679055401

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
Wockhardt Usa Llc.
FDA Application #
ANDA078871
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-09-2008
End Marketing Date
06-12-2019
Listing Expiration
06-12-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64679-554). Click a package code to view its specific billing and regulatory data.

64679-554-02
500 TABLET, FILM COATED in 1 BOTTLE
64679-554-03
100 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
64679-554-04
60 TABLET, FILM COATED 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 64679-554-01 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Risperidone, labeled by Wockhardt Usa Llc.. 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 Wockhardt Usa Llc. on October 09, 2008. The current certification is valid through June 12, 2019.

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 Wockhardt Usa Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64679055401. 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)
64679-554-01
11-Digit CMS (5-4-2)
64679-0554-01

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