Rexulti Tablet
NDC Package 70518-4608-0

11-digit billing NDC: 70518460800
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rexulti (brexpiprazole) tablets is rEXULTI is indicated for:Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adultsTreatment of schizophrenia in adults and pediatric patients ages 13 years and olderTreatment of agitation associated with dementia due to Alzheimer's diseaseLimitations of Use:REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3)]. This formulation utilizes a tablet delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4608 and is authorized under FDA application NDA205422.

Identification & Billing

NDC Package Code
70518-4608-0
Package Description
50 POUCH in 1 BOX / 1 TABLET in 1 POUCH (70518-4608-1)
Product Code
70518-4608
11-Digit Billing Format
70518460800
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 1 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
REXULTI is indicated for:Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adultsTreatment of schizophrenia in adults and pediatric patients ages 13 years and olderTreatment of agitation associated with dementia due to Alzheimer's diseaseLimitations of Use:REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3)] .

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205422
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-22-2026
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 70518-4608-0 identifies a specific commercial package of 50 pouch in 1 box / 1 tablet in 1 pouch (70518-4608-1) of Rexulti, a human prescription drug labeled by Remedyrepack 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 Remedyrepack Inc. on April 22, 2026. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518460800. 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)
70518-4608-0
11-Digit CMS (5-4-2)
70518-4608-00

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