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United States · US · US:64380-741_8b51cc64-78c9-4457-a523-161bc2049bdf
Buspirone Hydrochloride
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116438074106100 TABLET in 1 BOTTLE (64380-741-06)
- ndc116438074107500 TABLET in 1 BOTTLE (64380-741-07)
- ndc1164380741081000 TABLET in 1 BOTTLE (64380-741-08)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A202330
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": "64380-741_8b51cc64-78c9-4457-a523-161bc2049bdf",
"productndc": "64380-741",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202330",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 25, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 25, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Aug 25, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "004",
"approval_date": "Aug 25, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "005",
"approval_date": "Feb 17, 2017"
}
],
"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": "ANDA202330",
"marketing_category": "ANDA",
"nonproprietary_name": "Buspirone Hydrochloride",
"start_marketing_date": "20150630",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05BE01.
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