Risperidone Tablet, Orally Disintegrating
NDC Package 69292-575-28

11-digit billing NDC: 69292057528 · Billing unit: EA · 28 EA per package
Table of Contents
    1. Package Information
    2. 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 are supplied in blister packs of 30 (6 X 5)Risperidone Orally Disintegrating Tablets 1 mg, 2 mg, 3 mg and 4 mg are supplied in blister packe of 28 (4 X 7) Do not open the blister until ready to administer. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Amici Pharma, Inc., this product is identified by NDC 69292-575 and is authorized under FDA application ANDA077328.

Identification & Billing

NDC Package Code
69292-575-28
Package Description
7 BLISTER PACK in 1 CARTON / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
69292-575
11-Digit Billing Format
69292057528
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
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 4 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 are supplied in blister packs of 30 (6 X 5)Risperidone Orally Disintegrating Tablets 1 mg, 2 mg, 3 mg and 4 mg are supplied in blister packe of 28 (4 X 7) Do not open the blister until ready to administer. For single tablet removal, separate one of the five or seven blister units by tearing apart at the perforations. Bend the corner where indicated. Peel back foil 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 unit 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 unit. 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
Amici Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077328
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69292-575-28 identifies a specific commercial package of 7 blister pack in 1 carton / 4 tablet, orally disintegrating in 1 blister pack of Risperidone, a human prescription drug labeled by Amici Pharma, 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 Amici Pharma, Inc. on April 01, 2026. The current certification is valid through December 31, 2027.

How is this Amici Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69292057528. 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 (5-3-2)
69292-575-28
11-Digit CMS (5-4-2)
69292-0575-28

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