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United States · US · US:71335-2237_d18097c5-1c0f-4a7d-b1ea-eeed4f02d038
Buspirone hydrochloride
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11713352237130 TABLET in 1 BOTTLE (71335-2237-1)
- ndc11713352237290 TABLET in 1 BOTTLE (71335-2237-2)
- ndc11713352237318 TABLET in 1 BOTTLE (71335-2237-3)
- ndc11713352237428 TABLET in 1 BOTTLE (71335-2237-4)
- ndc11713352237560 TABLET in 1 BOTTLE (71335-2237-5)
- ndc117133522376120 TABLET in 1 BOTTLE (71335-2237-6)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A078888
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": "71335-2237_d18097c5-1c0f-4a7d-b1ea-eeed4f02d038",
"productndc": "71335-2237",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078888",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Feb 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Feb 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "004",
"approval_date": "Feb 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "005",
"approval_date": "Mar 21, 2023"
}
],
"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": "ANDA078888",
"marketing_category": "ANDA",
"nonproprietary_name": "Buspirone hydrochloride",
"start_marketing_date": "20230321",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code N05BE01.
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