Risperidone
NDC Package 0781-5313-08

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 Sandoz Inc, this product is identified by NDC 0781-5313 and is authorized under FDA application ANDA078116.

Identification & Billing

NDC Package Code
0781-5313-08
Package Description
28 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5313-06)
Product Code
0781-5313
11-Digit Billing Format
00781531308
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA

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
Sandoz Inc
FDA Application #
ANDA078116
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-22-2009
End Marketing Date
10-31-2020
Listing Expiration
10-31-2020
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 0781-5313-08 identifies a specific commercial package of 28 blister pack in 1 carton / 1 tablet, orally disintegrating in 1 blister pack (0781-5313-06) of Risperidone, labeled by Sandoz Inc. 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 Sandoz Inc on December 22, 2009. The current certification is valid through October 31, 2020.

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 Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781531308. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 total billable units per package. 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 (4-4-2)
0781-5313-08
11-Digit CMS (5-4-2)
00781-5313-08

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