Aripiprazole Tablet, Orally Disintegrating
NDC Package 76483-101-00

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

Package Information

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, orally disintegrating delivery system. Marketed by Square Pharmaceuticals Limited, this product is identified by NDC 76483-101 and is authorized under FDA application ANDA090165.

Identification & Billing

NDC Package Code
76483-101-00
Package Description
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
76483-101
11-Digit Billing Format
76483010100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aripiprazole
Non-Proprietary Name
Aripiprazole
Substance Name
Aripiprazole
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)
ARIPIPRAZOLE 15 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
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
Square Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-20-2022
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 (76483-101). Click a package code to view its specific billing and regulatory data.

76483-101-01
60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
76483-101-02
90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
76483-101-03
120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
76483-101-04
30 TABLET, ORALLY DISINTEGRATING in 1 CARTON

* 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 76483-101-00 identifies a specific commercial package of 30 tablet, orally disintegrating in 1 bottle of Aripiprazole, a human prescription drug labeled by Square Pharmaceuticals Limited. This tablet, orally disintegrating is formulated for oral 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 Square Pharmaceuticals Limited on July 20, 2022. 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 Square Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76483010100. 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)
76483-101-00
11-Digit CMS (5-4-2)
76483-0101-00

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