Exxua Tablet, Extended Release
NDC Package 23594-151-30

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

Package Information

Exxua (gepirone) tablets is eXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. . This formulation utilizes a tablet, extended release delivery system. Marketed by Aytu Therapeutics, Llc, this product is identified by NDC 23594-151 and is authorized under FDA application NDA021164.

Identification & Billing

NDC Package Code
23594-151-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
23594-151
11-Digit Billing Format
23594015130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 2672372 - gepirone 18.2 MG 24HR Extended Release Oral Tablet
  • RxCUI: 2672372 - 24 HR gepirone 18.2 MG Extended Release Oral Tablet
  • RxCUI: 2672372 - gepirone 18.2 MG (equivalent to 20 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet
  • RxCUI: 2672379 - EXXUA 18.2 MG 24HR Extended Release Oral Tablet
  • RxCUI: 2672379 - 24 HR gepirone 18.2 MG Extended Release Oral Tablet [Exxua]

Clinical Specifications

Proprietary Name
Exxua
Non-Proprietary Name
Gepirone
Substance Name
Gepirone Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GEPIRONE HYDROCHLORIDE 36.3 mg/1
Usage Information
EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. 

Regulatory & Marketing

Labeler Name
Aytu Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021164
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 23594-151-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Exxua, a human prescription drug labeled by Aytu Therapeutics, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, extended release is formulated for oral use and contains gepirone hydrochloride 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 Aytu Therapeutics, Llc on October 01, 2025. The current certification is valid through December 31, 2026.

How is this Aytu Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23594015130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
23594-151-30
11-Digit CMS (5-4-2)
23594-0151-30

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