Risperidone
NDC Package 69339-181-03

11-digit billing NDC: 69339018103
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 tablet Accessing Risperidone Orally Disintegrating Tablets, 0.25, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg: Risperidone orally disintegrating tablets, 0.25, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg are supplied in bottles containing 30 tablets.Tablet Administration Using dry hands, remove the tablet from the bottle and immediately place the entire risperidone orally disintegrating tablet on the tongue. Marketed by Natco Pharma Usa Llc, this product is identified by NDC 69339-181 and is authorized under FDA application ANDA091537.

Identification & Billing

NDC Package Code
69339-181-03
Package Description
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
69339-181
11-Digit Billing Format
69339018103

Clinical Specifications

Proprietary Name
Risperidone
Dosage Form
-
Usage Information
Tablet Accessing Risperidone Orally Disintegrating Tablets, 0.25, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg: Risperidone orally disintegrating tablets, 0.25, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg are supplied in bottles containing 30 tablets.Tablet Administration Using dry hands, remove the tablet from the bottle and immediately place the entire risperidone orally disintegrating tablet on the tongue. The risperidone orally disintegrating tablet should be consumed immediately. Risperidone orally disintegrating tablets disintegrate in the mouth within seconds and can be swallowed subsequently with or without liquid. Patients should not attempt to split or to chew the tablet.

Regulatory & Marketing

Labeler Name
Natco Pharma Usa Llc
FDA Application #
ANDA091537
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-14-2023
End Marketing Date
10-14-2023
Listing Expiration
10-14-2023
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 69339-181-03 identifies a specific commercial package of 30 tablet, orally disintegrating in 1 bottle of Risperidone, labeled by Natco Pharma 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 Natco Pharma Usa Llc on October 14, 2023. The current certification is valid through October 14, 2023.

How is this Natco Pharma Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69339018103. 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)
69339-181-03
11-Digit CMS (5-4-2)
69339-0181-03

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