🇺🇸
United States · US · US:80425-0334_2a9bad62-b308-697c-e063-6294a90aa395
BUSPIRONE HYDROCHLORIDE
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250334130 TABLET in 1 BOTTLE (80425-0334-1)
- ndc11804250334260 TABLET in 1 BOTTLE (80425-0334-2)
- ndc11804250334390 TABLET in 1 BOTTLE (80425-0334-3)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A078246
ABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "207LT9J9OC",
"rxcui": "203116",
"inchikey": "RICLFGYGYQXUFH-UHFFFAOYSA-N",
"display_name": "BUSPIRONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2c516eec-65d9-4481-8823-ae6b6da84062": {
"match": "brand_token",
"title": "BUSPIRONE HYDROCHLORIDE TABLET [IPG PHARMACEUTICALS, INC]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "80425-0334_2a9bad62-b308-697c-e063-6294a90aa395",
"productndc": "80425-0334",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078246",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Feb 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Feb 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "004",
"approval_date": "Feb 27, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "005",
"approval_date": "Feb 21, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUSPIRONE HYDROCHLORIDE",
"proprietary_name": "BUSPIRONE HYDROCHLORIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078246",
"marketing_category": "ANDA",
"nonproprietary_name": "BUSPIRONE HYDROCHLORIDE",
"start_marketing_date": "20230519",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05BE01.
Access this data programmatically
Query BUSPIRONE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.