Brexpiprazole Tablet
NDC Package 60274-939-05

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.

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 Societal Cdmo Gainesville, Llc, this product is identified by NDC 60274-939.

Identification & Billing

NDC Package Code
60274-939-05
Package Description
170000 TABLET in 1 DRUM
Product Code
60274-939
11-Digit Billing Format
60274093905

Clinical Specifications

Proprietary Name
Brexpiprazole
Non-Proprietary Name
Brexpiprazole
Substance Name
Brexpiprazole
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
BREXPIPRAZOLE 3 mg/1
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
Societal Cdmo Gainesville, Llc
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
03-02-2023
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 60274-939-05 identifies a specific commercial package of 170000 tablet in 1 drum of Brexpiprazole (UNFINISHED drug), drug for further processing labeled by Societal Cdmo Gainesville, Llc. This tablet is formulated for 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 Societal Cdmo Gainesville, Llc on March 02, 2023. The current certification is valid through December 31, 2026.

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 Societal Cdmo Gainesville, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60274093905. 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)
60274-939-05
11-Digit CMS (5-4-2)
60274-0939-05

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