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United States · US · US:69584-094_8c9f66ca-78a9-418c-b11e-ba4391843257
Buspirone Hydrochloride
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOxford Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11695840940660 TABLET in 1 BOTTLE (69584-094-06)
- ndc116958409418180 TABLET in 1 BOTTLE (69584-094-18)
- ndc116958409450500 TABLET in 1 BOTTLE (69584-094-50)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A078302
AB
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": "69584-094_8c9f66ca-78a9-418c-b11e-ba4391843257",
"productndc": "69584-094",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078302",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Dec 17, 2007"
}
],
"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": "ANDA078302",
"marketing_category": "ANDA",
"nonproprietary_name": "buspirone hydrochloride",
"start_marketing_date": "20200501",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N05BE01.
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