Regulatory PathRegulatory requirements compared

Active substance

Buspirone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BUSPAR 10MG TAB10 mgTablet · Oral use30 BlisterSAR 70.40NCE · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
BUSPAR 5MG TAB5 mgTablet · Oral use30 BlisterSAR 44.30NCE · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MGtablet · oralIMPAX LABS INCPrescription28 Mar 2001
BUSPIRONE HYDROCHLORIDE30MG; 5MG; 10MG; 15MGtablet · oralMYLANPrescription28 Jun 2001
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MGtablet · oralTEVAPrescription28 Feb 2002
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 7.5MG; 30MGtablet · oralRISINGPrescription19 Mar 2002
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 7.5MG; 30MGtablet · oralRUBICON RESEARCHPrescription5 Apr 2002
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MGtablet · oralOXFORD PHARMSPrescription9 May 2002
BUSPIRONE HYDROCHLORIDE30MGtablet · oralOXFORD PHARMSPrescription17 Dec 2007
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MG; 7.5MGtablet · oralAUROBINDO PHARMA LTDPrescription27 Feb 2009
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MG; 7.5MGtablet · oralZYDUS PHARMSPrescription7 Feb 2014
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MG; 7.5MGtablet · oralSTRIDES PHARMAPrescription25 Aug 2014
BUSPIRONE HYDROCHLORIDE5MG; 7.5MG; 10MG; 15MG; 30MGtablet · oralACCORD HLTHCAREPrescription30 Dec 2014
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MGtablet · oralHERITAGE PHARMAPrescription18 Sep 2015
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MG; 7.5MGtablet · oralAIPING PHARM INCPrescription16 Dec 2015
BUSPIRONE HYDROCHLORIDE5MG; 7.5MG; 10MG; 15MG; 30MGtablet · oralADAPTISPrescription3 May 2018
BUSPIRONE HYDROCHLORIDE5MG; 7.5MG; 10MG; 15MG; 30MG; 2.5MG; 12.5MGtablet · oralEPIC PHARMA LLCPrescription16 Apr 2019
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MG; 30MGtablet · oralUNICHEMPrescription14 Nov 2019
BUCAPSOL7.5MG; 10MG; 15MG; 5MGcapsule · oralEPIC PHARMA LLCPrescription13 Mar 2025
BUSPAR5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralBRISTOL MYERS SQUIBBDiscontinued29 Sep 1986
BUSPAR5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralBRISTOL MYERS SQUIBBDiscontinued20 Dec 2000
BUSPIRONE HYDROCHLORIDE5MG; 7.5MG; 10MG; 15MGtablet · oralMYLANDiscontinued28 Mar 2001
BUSPIRONE HYDROCHLORIDE7.5MGtablet · oralMYLANDiscontinued28 Jun 2001
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MGtablet · oralNESHER PHARMSDiscontinued27 Feb 2002
BUSPIRONE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralIVAX SUB TEVA PHARMSDiscontinued1 Mar 2002
BUSPIRONE HYDROCHLORIDE5MG; 10MG; 15MGtablet · oralEGISDiscontinued14 Mar 2002
BUSPIRONE HYDROCHLORIDE5MG; 7.5MG; 10MG; 15MG; 30MGtablet · oralAMNEAL PHARMS CODiscontinued24 May 2017

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AMB-BUSPIRONE0255055510 MGTABLET · ORALAMBICARE PHARMACEUTICALS INC.
AURO-BUSPIRONE0250021310 MGTABLET · ORALAURO PHARMA INC
BUSPIRONE TABLETS0256812810 MGTABLET · ORALSANIS HEALTH INC
JAMP BUSPIRONE0250991110 MGTABLET · ORALJAMP PHARMA CORPORATION
MINT-BUSPIRONE0251905410 MGTABLET · ORALMINT PHARMACEUTICALS INC
PMS-BUSPIRONE0223094210 MGTABLET · ORALPHARMASCIENCE INC
PRO-BUSPIRONE0222316310 MGTABLET · ORALPRO DOC LIMITEE
TEVA-BUSPIRONE0223149210 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBUSPIRONE HCL 10 MG TABLET$0.02795per EA30 Sep 2026
US NADACBUSPIRONE HCL 15 MG TABLET$0.04296per EA7 Oct 2026
US NADACBUSPIRONE HCL 30 MG TABLET$0.11985per EA23 Sep 2026
US NADACBUSPIRONE HCL 5 MG TABLET$0.02195per EA30 Sep 2026
US NADACBUSPIRONE HCL 7.5 MG TABLET$0.1003per EA30 Sep 2026
NHS Drug TariffBuspirone 10mg tablets£1.7730 tablet1 Oct 2026
NHS Drug TariffBuspirone 15mg tablets£23.3330 tablet1 Oct 2026
NHS Drug TariffBuspirone 5mg tablets£1.4130 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.