Viewing data from:

FLUOXETINE HYDROCHLORIDE

ANDA

FLUOXETINE HYDROCHLORIDE | A075465 | MARKSANS PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 7 NDCs

Highest NADAC/Unit

$0.0499

per ea

Lowest NADAC/Unit

$0.0289

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49483070303FLUOXETINE HCL 40 MG CAPSULE	$0.0499	EA	Generic	—	2026-08-19
49483070350FLUOXETINE HCL 40 MG CAPSULE	$0.0499	EA	Generic	—	2026-08-19
49483070301FLUOXETINE HCL 40 MG CAPSULE	$0.0499	EA	Generic	—	2026-08-19
49483070110FLUOXETINE HCL 10 MG CAPSULE	$0.0362	EA	Generic	—	2026-08-19
49483070101FLUOXETINE HCL 10 MG CAPSULE	$0.0362	EA	Generic	—	2026-08-19
49483070210FLUOXETINE HCL 20 MG CAPSULE	$0.0289	EA	Generic	—	2026-08-19
49483070201FLUOXETINE HCL 20 MG CAPSULE	$0.0289	EA	Generic	—	2026-08-19

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

API Supply Chain13 active DMFs10 inactive

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

OLON SPAFLUOXETINE HYDROCHLORIDE

DMF 86951990

ERREGIERRE SPAFLUOXETINE HYDROCHLORIDE USP-EP

DMF 108371994

FERMION OYFLUOXETINE HYDROCHLORIDE USP

DMF 113151995

OLON SPAFLUOXETINE HYDROCHLORIDE

DMF 120091996

QUIMICA SINTETICA SAFLUOXETINE HYDROCHLORIDE

DMF 122911996

DR REDDYS LABORATORIES LTDFLUOXETINE HYDROCHLORIDE USP

DMF 130691998

CADILA PHARMACEUTICALS LTDFLUOXETINE HYDROCHLORIDE USP

DMF 142531999

APITORIA PHARMA PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP

DMF 189802005

SIEGFRIED LTDFLUOXETINE HYDROCHLORIDE

DMF 217682008

ALEMBIC PHARMACEUTICALS LTDFLUOXETINE HYDROCHLORIDE USP

DMF 257782012

APITORIA PHARMA PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP (PROCESS II)

DMF 339402019

IPCA LABORATORIES LTDFLUOXETINE HYDROCHLORIDE USP

DMF 409692024

CHEMECA DRUGS PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP

DMF 426682025

LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COInactiveFLUOXETINE HYDROCHLORIDE, BULK

DMF 46731982

NATCO PHARMA LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 119921996

INDUSTRIALE CHIMICA SRLInactiveFLUOXETINE HYDROCHLORIDE

DMF 122921996

SIEGFRIED LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 124371997

UNION QUIMICO FARMACEUTICA SAInactiveFLUOXETINE HYDROCHLORIDE, USP

DMF 126311997

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveFLUOXETINE HYDROCHLORIDE

DMF 130261998

WOCKHARDT LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 142891999

RANBAXY LABORATORIES LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 153622001

WOCKHARDT LTDInactiveFLUOXETINE HYDROCHLORIDE USP

DMF 181772005

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 199802006

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 4, 2004	ORIG -1	View Letter (PDF)
Jun 4, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 10MG BASE

AB1

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 29, 2002

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

AB1

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 29, 2002

#003 — EQ 40MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 2, 2001