Risperidone Kit
NDC Package 71161-131-01

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 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.

Risperidone kits is risperidone is used to treat a certain mental/mood disorder called schizophrenia. This formulation utilizes a kit delivery system. Marketed by Synergy Health Ast, Llc, this product is identified by NDC 71161-131.

Identification & Billing

NDC Package Code
71161-131-01
Package Description
1 KIT in 1 CARTON * 1 SYRINGE in 1 POUCH / 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (71161-139-02) / 1 mL in 1 SYRINGE (71161-139-05)
Product Code
71161-131
11-Digit Billing Format
71161013101

Clinical Specifications

Proprietary Name
Risperidone
Non-Proprietary Name
Risperidone
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Risperidone is used to treat a certain mental/mood disorder called schizophrenia. This medication can decrease hallucinations, help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Risperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural substances in the brain.

Regulatory & Marketing

Labeler Name
Synergy Health Ast, Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-09-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71161-131). Click a package code to view its specific billing and regulatory data.

71161-131-09
1 KIT in 1 CARTON * 1 SYRINGE in 1 POUCH / 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (71161-139-02) / 1 mL in 1 SYRINGE (71161-139-05)

* 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 71161-131-01 identifies a specific commercial package of 1 kit in 1 carton * 1 syringe in 1 pouch / 1.2 ml in 1 syringe * 1 syringe in 1 pouch (71161-139-02) / 1 ml in 1 syringe (71161-139-05) of Risperidone (UNFINISHED drug), drug for further processing labeled by Synergy Health Ast, Llc. This kit is formulated for use and contains 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 Synergy Health Ast, Llc on November 09, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Risperidone is used to treat a certain mental/mood disorder called schizophrenia. This medication can decrease hallucinations, help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Risperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural substances in the brain.

How is this Synergy Health Ast, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71161013101. 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)
71161-131-01
11-Digit CMS (5-4-2)
71161-0131-01

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