NDC Package 65862-167-01 Risperidone

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

65862-167-01

Package Description:

1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

Product Code:

65862-167

Proprietary Name:

Risperidone

Non-Proprietary Name:

Risperidone

Substance Name:

Risperidone

Usage Information:

Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life. Risperidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

11-Digit NDC Billing Format:

65862016701

NDC to RxNorm Crosswalk:

RxCUI: 199387 - risperiDONE 1 MG in 1 mL Oral Solution

RxCUI: 199387 - risperidone 1 MG/ML Oral Solution

RxCUI: 199387 - risperidone 1 MG per 1 ML Oral Solution

Product Type:

Human Prescription Drug

Labeler Name:

Aurobindo Pharma Limited

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

RISPERIDONE 1 mg/mL

Pharmacologic Class(es):

Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)

Sample Package:

FDA Application Number:

ANDA078452

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

03-25-2019

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

65862 - Aurobindo Pharma Limited
- 65862-167 - Risperidone
  - 65862-167-01 - 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
65862-167-30	1 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 65862-167-01?

The NDC Packaged Code 65862-167-01 is assigned to a package of 1 bottle in 1 carton / 30 ml in 1 bottle of Risperidone, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is solution and is administered via oral form.

Is NDC 65862-167 included in the NDC Directory?

Yes, Risperidone with product code 65862-167 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on March 25, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 65862-167-01?

The 11-digit format is 65862016701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	65862-167-01	5-4-2	65862-0167-01

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