EXXUA

Orange BookUNIISPLATC N06AX19

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAytu Therapeutics, LLC

CountryUS (United States)

ATC codeN06AX19

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2359415330
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30)

Annotations

UNII (FDA Substance ID)

80C9L8EP6V

GEPIRONE HYDROCHLORIDE

Orange Book

N021164

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "80C9L8EP6V",
    "rxcui": null,
    "inchikey": "DGOCVISYYYQFEP-UHFFFAOYSA-N",
    "display_name": "GEPIRONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0c78edd8-6acb-433c-9d34-2527da8d64e1": {
      "match": "brand_token",
      "title": "EXXUA (GEPIRONE) TABLET, EXTENDED RELEASE [AYTU THERAPEUTICS, LLC]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "23594-153_414d62f1-85aa-cfa6-e063-6394a90a69fc",
  "productndc": "23594-153",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021164",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 18.2MG BASE",
        "product_no": "001",
        "approval_date": "Sep 22, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 36.3MG BASE",
        "product_no": "002",
        "approval_date": "Sep 22, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 54.5MG BASE",
        "product_no": "003",
        "approval_date": "Sep 22, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 72.6MG BASE",
        "product_no": "004",
        "approval_date": "Sep 22, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GEPIRONE HYDROCHLORIDE",
  "proprietary_name": "EXXUA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021164",
  "marketing_category": "NDA",
  "nonproprietary_name": "gepirone",
  "start_marketing_date": "20251001",
  "active_numerator_strength": "72.6"
}

Related drugs

Other records sharing ATC code N06AX19.

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