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United States · US · US:23594-150_414d62f1-85aa-cfa6-e063-6394a90a69fc
EXXUA
Orange BookUNIISPLATC N06AX19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAytu Therapeutics, LLC
CountryUS (United States)
ATC codeN06AX19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11235941503030 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-30)
- ndc11235941503232 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-32)
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": "23594-150_414d62f1-85aa-cfa6-e063-6394a90a69fc",
"productndc": "23594-150",
"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": "18.2"
}Related drugs
Other records sharing ATC code N06AX19.
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