Aripiprazole Tablet
NDC Package 46602-0010-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Aripiprazole tablets is aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). This formulation utilizes a tablet delivery system. Marketed by Otsuka Pharmaceutical Co., Ltd., this product is identified by NDC 46602-0010.

Identification & Billing

NDC Package Code
46602-0010-5
Package Description
82000 TABLET in 1 DRUM
Product Code
46602-0010
11-Digit Billing Format
46602001005

Clinical Specifications

Proprietary Name
Aripiprazole
Non-Proprietary Name
Aripiprazole
Substance Name
Aripiprazole
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
ARIPIPRAZOLE 20 mg/1
Usage Information
Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazole is known as an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. Aripiprazole can treat severe mood swings and decrease how often mood swings occur.

Regulatory & Marketing

Labeler Name
Otsuka Pharmaceutical Co., Ltd.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-01-2002
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 46602-0010-5 identifies a specific commercial package of 82000 tablet in 1 drum of Aripiprazole (UNFINISHED drug), drug for further processing labeled by Otsuka Pharmaceutical Co., Ltd.. This tablet is formulated for use and contains aripiprazole 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 Otsuka Pharmaceutical Co., Ltd. on December 01, 2002. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazole is known as an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. Aripiprazole can treat severe mood swings and decrease how often mood swings occur.

How is this Otsuka Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46602001005. 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 (5-4-1)
46602-0010-5
11-Digit CMS (5-4-2)
46602-0010-05

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