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United States · US · US:80425-0303_2a9c0c91-2b32-4def-e063-6294a90a58ef
Buspirone Hydrochloride
Orange BookUNIISPLATC N05BE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeN05BE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250303130 TABLET in 1 BOTTLE (80425-0303-1)
- ndc11804250303260 TABLET in 1 BOTTLE (80425-0303-2)
- ndc11804250303390 TABLET in 1 BOTTLE (80425-0303-3)
Annotations
UNII (FDA Substance ID)
207LT9J9OC
BUSPIRONE HYDROCHLORIDE
RxCUI 203116
Orange Book
A210907
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": "80425-0303_2a9c0c91-2b32-4def-e063-6294a90a58ef",
"productndc": "80425-0303",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210907",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Nov 14, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Nov 14, 2019"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Nov 14, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "004",
"approval_date": "Nov 14, 2019"
}
],
"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": "ANDA210907",
"marketing_category": "ANDA",
"nonproprietary_name": "Buspirone Hydrochloride",
"start_marketing_date": "20230406",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N05BE01.
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