Risperidone Solution
NDC Package 83745-186-30

11-digit billing NDC: 83745018630 · Billing unit: ML · 30 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Risperidone solution is risperidone oral solution is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone oral solution formulation. This formulation utilizes a solution delivery system. Marketed by Apozeal Pharmaceuticals Inc, this product is identified by NDC 83745-186 and is authorized under FDA application ANDA078909.

Identification & Billing

NDC Package Code
83745-186-30
Package Description
30 mL in 1 BOTTLE
Product Code
83745-186
11-Digit Billing Format
83745018630
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Risperidone
Non-Proprietary Name
Risperidone
Substance Name
Risperidone
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RISPERIDONE 1 mg/mL
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Risperidone oral solution is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone oral solution formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.

Regulatory & Marketing

Labeler Name
Apozeal Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA078909
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2025
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 83745-186-30 identifies a specific commercial package of 30 ml in 1 bottle of Risperidone, a human prescription drug labeled by Apozeal Pharmaceuticals Inc. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. This solution 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 Apozeal Pharmaceuticals Inc on January 31, 2025. The current certification is valid through December 31, 2027.

How is this Apozeal Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83745018630. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 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)
83745-186-30
11-Digit CMS (5-4-2)
83745-0186-30

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