Viewing data from:

BUSPIRONE HYDROCHLORIDE

ANDA

BUSPIRONE HYDROCHLORIDE | A075521 | RUBICON RESEARCH LTD

5 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 11 NDCs

Highest NADAC/Unit

$0.1229

per ea

Lowest NADAC/Unit

$0.0218

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72888006605BUSPIRONE HCL 30 MG TABLET	$0.1229	EA	Generic	—	2026-10-21
72888006660BUSPIRONE HCL 30 MG TABLET	$0.1229	EA	Generic	—	2026-10-21
72888006305BUSPIRONE HCL 7.5 MG TABLET	$0.0998	EA	Generic	—	2026-10-21
72888006301BUSPIRONE HCL 7.5 MG TABLET	$0.0998	EA	Generic	—	2026-10-21
72888006505BUSPIRONE HCL 15 MG TABLET	$0.0431	EA	Generic	—	2026-10-21
72888006560BUSPIRONE HCL 15 MG TABLET	$0.0431	EA	Generic	—	2026-10-21

Showing 6 of 11 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain12 active DMFs11 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

EXCELLA GMBH AND CO KGBUSPIRONE HYDROCHLORIDE

DMF 91671991

FERMION OYBUSPIRONE HYDROCHLORIDE

DMF 111481994

UNIMARK REMEDIES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 253612011

UNICHEM LABORATORIES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 297042015

ZYDUS LIFESCIENCES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 334312018

SOLARA ACTIVE PHARMA SCIENCES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 354882020

MAITHRI LABORATORIES PRIVATE LTDBUSPIRONE HYDROCHLORIDE USP

DMF 381092023

EMCURE PHARMACEUTICALS LTDBUSPIRONE HYDROCHLORIDE USP

DMF 384122023

MEDILUX LABORATORIES PVT LTDBUSPIRONE HYDROCHLORIDE USP

DMF 402662024

R L FINE CHEM PVT LTDBUSPIRONE HYDROCHLORIDE

DMF 405852024

JIANGSU NHWA PHARMACEUTICAL CO LTDBUSPIRONE HYDROCHLORIDE USP

DMF 409742024

COHANCE LIFESCIENCES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 411762025

GANES CHEMICALS INC PENNSVILLE DIVInactiveBUSPIRONE HYDROCHLORIDE

DMF 53971984

CYCLO PRODUCTS INCInactiveBUSPIRONE HYDROCHLORIDE

DMF 64181986

APOTEX PHARMACHEM INCInactiveBUSPIRONE HYDROCHLORIDE

DMF 89281991

QUIMICA SINTETICA SAInactiveBUSPIRONE

DMF 91891991

BIOCHIMICA OPOS 2 SPAInactiveBUSPIRONE HYDROCHLORIDE

DMF 98021992

ARCHIMICA SPAInactiveBUSPIRONE HYDROCHLORIDE

DMF 104141993

MEDICHEM SAInactiveBUSPIRONE HYDROCHLORIDE

DMF 114691995

ALKALOIDA CHEMICAL CO ZRTInactiveBUSPIRONE HYDROCHLORIDE

DMF 121721996

EGIS PHARMACEUTICALS PRIVATE LTDInactiveBUSPIRONE HYDROCHLORIDE USP BULK

DMF 123501997

INDUSTRIALE CHIMICA SRLInactiveBUSPIRONE HYDROCHLORIDE

DMF 126841997

SOUTHWEST SYNTHETIC PHARMACEUTICAL GENERAL FACTORYInactiveBUSPIRONE HYDROCHLORIDE

DMF 151632000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 28, 2004	ORIG -1	View Letter (PDF)
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 5, 2002

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 5, 2002

#003 — 15MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 5, 2002

#004 — 7.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 16, 2021

#005 — 30MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 16, 2021