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PAROXETINE HYDROCHLORIDE

ANDA

PAROXETINE HYDROCHLORIDE | A075356 | APOTEX INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PAXIL(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 14 NDCs

Highest NADAC/Unit

$0.1037

per ea

Lowest NADAC/Unit

$0.0643

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60505010104PAROXETINE HCL 40 MG TABLET	$0.1037	EA	Generic	—	2026-06-17
60505010102PAROXETINE HCL 40 MG TABLET	$0.1037	EA	Generic	—	2026-06-17
60505010101PAROXETINE HCL 40 MG TABLET	$0.1037	EA	Generic	—	2026-06-17
60505008401PAROXETINE HCL 30 MG TABLET	$0.0947	EA	Generic	—	2026-06-17
60505008402PAROXETINE HCL 30 MG TABLET	$0.0947	EA	Generic	—	2026-06-17
60505008404PAROXETINE HCL 30 MG TABLET	$0.0947	EA	Generic	—	2026-06-17

Showing 6 of 14 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (14 FSS)

Lowest Price

$2.60

Highest Price

$118.40

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60429-0736-10PAROXETINE HCL 30MG TAB	$114.55	FSS	Golden State Medical Supply, Inc.	06/14/2028
60429-0736-30PAROXETINE HCL 30MG TAB	$4.53	FSS	Golden State Medical Supply, Inc.	06/14/2028
60429-0736-90PAROXETINE HCL 30MG TAB	$11.59	FSS	Golden State Medical Supply, Inc.	06/14/2028
60429-0737-10PAROXETINE HCL 40MG TAB	$118.40	FSS	Golden State Medical Supply, Inc.	06/14/2028
60429-0737-30PAROXETINE HCL 40MG TAB	$4.64	FSS	Golden State Medical Supply, Inc.	06/14/2028
60429-0737-90PAROXETINE HCL 40MG TAB	$11.40	FSS	Golden State Medical Supply, Inc.	06/14/2028

Showing 6 of 14 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain13 active DMFs13 inactive

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

GLAXOSMITHKLINEPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 150392000

ZYDUS LIFESCIENCES LTDPAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE)

DMF 166802003

MEDICHEM SAPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 180522005

APITORIA PHARMA PRIVATE LTDPAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP

DMF 191522006

SUN PHARMACEUTICAL INDUSTRIES LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 191782006

ORCHID PHARMA LTDPAROXETINE HYDROCHLORIDE

DMF 197512006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 199222006

WANBURY LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 202482006

APOTEX INCPAROXETINE HYDROCHLORIDE ANHYDROUS USP

DMF 214402008

SIGNA SA DE CVPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 287632014

MATRIX PHARMACORP PRIVATE LTDPAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE)

DMF 387932023

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDPAROXETINE HYDROCHLORIDE

DMF 403252024

ZHEJIANG HAISEN PHARMACEUTICAL CO LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 433452025

APOTEX PHARMACHEM INCInactivePAROXETINE HYDROCHLORIDE (ANHYDROUS)

DMF 127701997

SUMITOMO CHEMICAL CO LTDInactivePAROXETINE HYDROCHLORIDE ANHYDRATE

DMF 138881998

ASAHI GLASS CO LTDInactivePAROXETINE HYDROCHLORIDE AMORPHOUS

DMF 144321999

GLAXOSMITHKLINEInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 144751999

AESICA PHARMACEUTICALS LTDInactivePAROXETINE HYDROCHLORIDE

DMF 149132000

ITF CHEMICAL LTDAInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 162472002

TEVA PHARMACEUTICAL INDUSTRIES LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 164162003

CADILA HEALTHCARE LTDInactivePAROXETINE HYDROCHLORIDE, ANHYDROUS

DMF 172862004

RECORDATI ESPANA SLInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 172932004

TAIZHOU HIGHSUN PHARMACEUTICAL CO LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 198032006

DR REDDYS LABORATORIES LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 199702006

IPCA LABORATORIES LTDInactivePAROXETINE HYDROCHLORIDE

DMF 210072008

AESICA PHARMACEUTICALS LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 249602011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 31, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 10MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 30, 2003

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 30, 2003

#003 — EQ 30MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 30, 2003

#004 — EQ 40MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 30, 2003