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United States · US · US:71610-974_4df36eb1-1f18-3857-e063-6394a90a1c89
Buspirone Hydrochloride
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11716109743030 TABLET in 1 BOTTLE (71610-974-30)
- ndc11716109745360 TABLET in 1 BOTTLE (71610-974-53)
- ndc11716109746090 TABLET in 1 BOTTLE (71610-974-60)
- ndc117161097470120 TABLET in 1 BOTTLE (71610-974-70)
- ndc117161097480180 TABLET in 1 BOTTLE (71610-974-80)
- ndc117161097492270 TABLET in 1 BOTTLE (71610-974-92)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A075022
ABABABAB
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": "71610-974_4df36eb1-1f18-3857-e063-6394a90a1c89",
"productndc": "71610-974",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075022",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 28, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Feb 28, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Feb 28, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "004",
"approval_date": "Mar 25, 2004"
}
],
"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": "ANDA075022",
"marketing_category": "ANDA",
"nonproprietary_name": "Buspirone Hydrochloride",
"start_marketing_date": "20020228",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BE01.
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