Rexulti Tablet
NDC Package 59148-040-07

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

Rexulti (brexpiprazole) tablets is a medication used to treat certain mental/mood disorders (such as schizophrenia, depression). This formulation utilizes a tablet delivery system. Marketed by Otsuka America Pharmaceutical, Inc., this product is identified by NDC 59148-040 and is authorized under FDA application NDA205422.

Identification & Billing

NDC Package Code
59148-040-07
Package Description
1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK
Product Code
59148-040
11-Digit Billing Format
59148004007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rexulti
Non-Proprietary Name
Brexpiprazole
Substance Name
Brexpiprazole
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BREXPIPRAZOLE 4 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression). Brexpiprazole helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Brexpiprazole is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Regulatory & Marketing

Labeler Name
Otsuka America Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205422
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-10-2015
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (59148-040). Click a package code to view its specific billing and regulatory data.

59148-040-13
1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE

* 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 59148-040-07 identifies a specific commercial package of 1 blister pack in 1 carton / 7 tablet in 1 blister pack of Rexulti, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc.. This tablet is formulated for oral use and contains brexpiprazole 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 America Pharmaceutical, Inc. on July 10, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression). Brexpiprazole helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Brexpiprazole is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

How is this Otsuka America Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59148004007. 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)
59148-040-07
11-Digit CMS (5-4-2)
59148-0040-07

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