United States· US:23594-150_414d62f1-85aa-cfa6-e063-6394a90a69fc

EXXUA

A gepirone product containing gepirone hydrochloride, registered in United States by Aytu Therapeutics, LLC.

ATC N06AX19US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedEXXUAATCN06AX19REGISTER NO.US:23594-150_414d62f1…PACKS LISTED4CHECKEDJuly 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
GEPIRONE HYDROCHLORIDE
Manufacturer
Aytu Therapeutics, LLC
Country
United States (US)
ATC code
N06AX19
ATC class
Gepirone
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 12, 2026

Packs & prices · 4

  • ndc11
    23594-150-30
  • ndc11
    23594-150-32
  • ndc11
    2359415030
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-30)
  • ndc11
    2359415032
    32 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-32)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/c368390d-ea95-4e01-813b-9adeab06f734
GET /v1/drugs/c368390d-ea95-4e01-813b-9adeab06f734?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "18.2",
  "substance": "GEPIRONE HYDROCHLORIDE",
  "productndc": "23594-150",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA021164",
  "marketing_category": "NDA"
}

See everything about gepirone.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.