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United States · US · US:81279-124_4dc3284b-c414-6249-e063-6394a90a5d7b
Bucapsol
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPANGEA PHARMACEUTICALS, LLC
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11812791243030 CAPSULE in 1 BOTTLE (81279-124-30)
- ndc11812791246060 CAPSULE in 1 BOTTLE (81279-124-60)
Annotations
UNII (FDA Substance ID)
TK65WKS8HL
BUSPIRONE
RxCUI 1827
Orange Book
A218628
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TK65WKS8HL",
"rxcui": "1827",
"inchikey": "QWCRAEMEVRGPNT-UHFFFAOYSA-N",
"display_name": "BUSPIRONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f101c5f3-d533-474d-a8bf-90d054933d16": {
"match": "brand_token",
"title": "BUCAPSOL (BUSPIRONE HYDROCHLORIDE) CAPSULE [PANGEA PHARMACEUTICALS, LLC]",
"spl_version": "5",
"published_date": "2026-04-10"
}
},
"productid": "81279-124_4dc3284b-c414-6249-e063-6394a90a5d7b",
"productndc": "81279-124",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218628",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "7.5MG",
"product_no": "001",
"approval_date": "Mar 13, 2025"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 13, 2025"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "15MG",
"product_no": "003",
"approval_date": "Mar 13, 2025"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "004",
"approval_date": "Apr 29, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUSPIRONE",
"proprietary_name": "Bucapsol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218628",
"marketing_category": "ANDA",
"nonproprietary_name": "Buspirone Hydrochloride",
"start_marketing_date": "20250714",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N05BE01.
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