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United States · US · US:82804-963_1521109d-8386-472f-9483-f1fe9f7ed152
Buspirone Hydrochloride
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc118280496300100 TABLET in 1 BOTTLE (82804-963-00)
- ndc1182804963111000 TABLET in 1 BOTTLE (82804-963-11)
- ndc11828049633030 TABLET in 1 BOTTLE (82804-963-30)
- ndc118280496355500 TABLET in 1 BOTTLE (82804-963-55)
- ndc11828049636060 TABLET in 1 BOTTLE (82804-963-60)
- ndc118280496372120 TABLET in 1 BOTTLE (82804-963-72)
- ndc11828049639090 TABLET in 1 BOTTLE (82804-963-90)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A075388
ABABAB
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": "82804-963_1521109d-8386-472f-9483-f1fe9f7ed152",
"productndc": "82804-963",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075388",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 9, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "May 9, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "May 9, 2002"
}
],
"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": "ANDA075388",
"marketing_category": "ANDA",
"nonproprietary_name": "buspirone hydrochloride",
"start_marketing_date": "20200727",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N05BE01.
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