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United States · US · US:71335-1144_642c0480-01e4-4770-88e4-d2644656f3f3
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
- ndc11713351144130 TABLET in 1 BOTTLE (71335-1144-1)
- ndc11713351144260 TABLET in 1 BOTTLE (71335-1144-2)
- ndc11713351144390 TABLET in 1 BOTTLE (71335-1144-3)
- ndc11713351144445 TABLET in 1 BOTTLE (71335-1144-4)
- ndc117133511445180 TABLET in 1 BOTTLE (71335-1144-5)
- ndc117133511446120 TABLET in 1 BOTTLE (71335-1144-6)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A209696
BXBXBXBXBX
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": "71335-1144_642c0480-01e4-4770-88e4-d2644656f3f3",
"productndc": "71335-1144",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209696",
"products": [
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 3, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "7.5MG",
"product_no": "002",
"approval_date": "May 3, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "10MG",
"product_no": "003",
"approval_date": "May 3, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "15MG",
"product_no": "004",
"approval_date": "May 3, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "30MG",
"product_no": "005",
"approval_date": "May 3, 2018"
}
],
"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": "ANDA209696",
"marketing_category": "ANDA",
"nonproprietary_name": "Buspirone Hydrochloride",
"start_marketing_date": "20240617",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BE01.
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