Risperidone Tablet, Orally Disintegrating
NDC Package 63304-643-05

11-digit billing NDC: 63304064305
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Risperidone tablets is tablet AccessingRisperidone orally disintegrating tablets 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mgRisperidone orally disintegrating tablets 0.5 mg, 1 mg, and 2 mg are supplied in bottles and unit-dose pouch packs.Risperidone orally disintegrating tablets 3 mg and 4 mg are supplied in bottles and blister or unit-dose pouch packs.The child-resistant pouch should be torn open at the notch to access the blister. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 63304-643 and is authorized under FDA application ANDA078474.

Identification & Billing

NDC Package Code
63304-643-05
Package Description
500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
63304-643
11-Digit Billing Format
63304064305
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Risperidone
Non-Proprietary Name
Risperidone
Substance Name
Risperidone
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RISPERIDONE 3 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Tablet AccessingRisperidone orally disintegrating tablets 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mgRisperidone orally disintegrating tablets 0.5 mg, 1 mg, and 2 mg are supplied in bottles and unit-dose pouch packs.Risperidone orally disintegrating tablets 3 mg and 4 mg are supplied in bottles and blister or unit-dose pouch packs.The child-resistant pouch should be torn open at the notch to access the blister. Do not open the blister until ready to administer. Peel back foil from the side to expose the tablet. DO NOT push the tablet through the foil, because this could damage the tablet.Tablet AdministrationUsing dry hands, remove the tablet from the blister or pouch and immediately place the entire risperidone orally disintegrating tablet on the tongue. The risperidone orally disintegrating tablet should be consumed immediately, as the tablet cannot be stored once removed from the blister or pouch. 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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078474
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-06-2010
Listing Expiration
12-31-2026
Exclude Flag
N
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 (63304-643). Click a package code to view its specific billing and regulatory data.

63304-643-17
10 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11)
63304-643-30
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
63304-643-69
1 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

* 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 63304-643-05 identifies a specific commercial package of 500 tablet, orally disintegrating in 1 bottle of Risperidone, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, orally disintegrating is formulated for oral use and contains risperidone 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 Sun Pharmaceutical Industries, Inc. on August 06, 2010. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304064305. 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)
63304-643-05
11-Digit CMS (5-4-2)
63304-0643-05

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