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DULOXETINE HYDROCHLORIDE

ANDA

DULOXETINE HYDROCHLORIDE | A090778 | AUROBINDO PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$0.1293

per ea

Lowest NADAC/Unit

$0.1173

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
57237001999DULOXETINE HCL DR 60 MG CAP	$0.1293	EA	Generic	—	2026-08-19
57237001760DULOXETINE HCL DR 20 MG CAP	$0.1173	EA	Generic	—	2026-08-19

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

API Supply Chain33 active DMFs15 inactive

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

DR REDDYS LABORATORIES LTDDULOXETINE HYDROCHLORIDE

DMF 202962007

MSN LABORATORIES PRIVATE LTDDULOXETINE HYDROCHLORIDE USP [ROUTE CODE - DX"]

DMF 209962007

MATRIX PHARMACORP PRIVATE LTDDULOXETINE HYDROCHLORIDE USP

DMF 214782008

TORRENT PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE USP

DMF 214852008

LUPIN LTDDULOXETINE HYDROCHLORIDE USP

DMF 215242008

WOCKHARDT LTDDULOXETINE HYDROCHLORIDE USP

DMF 216042008

ORBION PHARMACEUTICALS PRIVATE LTDDULOXETINE HYDROCHLORIDE (NON-STERILE BULK API)

DMF 216352008

SUN PHARMACEUTICAL INDUSTRIES LTDDULOXETINE HYDROCHLORIDE USP

DMF 217522008

APITORIA PHARMA PRIVATE LTDDULOXETINE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 217672008

SIGNA SA DE CVDULOXETINE HYDROCHLORIDE USP

DMF 218332008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE, USP

DMF 230512009

ALEMBIC PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE USP

DMF 237022010

ALKEM LABORATORIES LTDDULOXETINE HYDROCHLORIDE

DMF 246852011

SCI PHARMTECH INCDULOXETINE HYDROCHLORIDE

DMF 249392011

MACLEODS PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE

DMF 250362011

HETERO DRUGS LTDDULOXETINE HYDROCHLORIDE

DMF 252802011

JUBILANT PHARMOVA LTDDULOXETINE HYDROCHLORIDE

DMF 258902012

ZYDUS LIFESCIENCES LTDDULOXETINE HYDROCHLORIDE USP (PROCESS-II)

DMF 283902014

LUPIN LTDDULOXETINE HYDROCHLORIDE USP (PROCESS B)

DMF 289612015

ZHEJIANG LIAOYUAN PHARMACEUTICALS CO LTDDULOXETINE HYDROCHLORIDE

DMF 295002015

MACLEODS PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE DELAYED-RELEASE PELLETS

DMF 298992015

HEC PHARM CO LTDDULOXETINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE

DMF 301722016

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 301742016

ALEMBIC PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE USP (DUX PROCES)

DMF 303902016

RL FINE CHEM PVT LTDDULOXETINE HYDROCHLORIDE

DMF 330722018

APITORIA PHARMA PRIVATE LTDDULOXETINE HYDROCHLORIDE USP (PROCESS II)

DMF 336332019

SHANGHAI WONDER PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE

DMF 346782020

MSN LABORATORIES PRIVATE LTDDULOXETINE HYDROCHLORIDE USP

DMF 358052021

MOEHS IBERICA SLDULOXETINE HYDROCHLORIDE

DMF 368342022

AJANTA PHARMA LTDDULOXETINE HYDROCHLORIDE USP

DMF 374582022

SHODHANA LABORATORIES PRIVATE LTDDULOXETINE HYDROCHLORIDE [USP]

DMF 401652024

IPCA LABORATORIES LTDDULOXETINE HYDROCHLORIDE USP

DMF 402822024

SHANKUS PHARMA PRIVATE LTDDULOXETINE HYDROCHLORIDE EP/BP

DMF 432202025

CADILA HEALTHCARE LTDInactiveDULOXETINE HYDROCHLORIDE USP

DMF 196312006

MATRIX LABORATORIES LTDInactiveDULOXETINE HYDROCHLORIDE

DMF 198602006

OLON SPAInactiveDULOXETINE HYDROCHLORIDE

DMF 199742006

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveDULOXETINE HYDROCHLORIDE

DMF 213852008

RANBAXY LABORATORIES LTDInactiveDULOXETINE HYDROCHLORIDE DRUG SUBSTANCE

DMF 218382008

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCHInactiveDULOXETINE HYDROCHLORIDE

DMF 220862008

CADILA PHARMACEUTICALS LTDInactiveDULOXETINE HYDROCHLORIDE

DMF 228672009

ERREGIERRE SPAInactiveDULOXETINE HYDROCHLORIDE EP-USP

DMF 231332009

SCI PHARMTECH INCInactiveDULOXETINE HYDROCHLORIDE (FROM (S)-MMAA-OME)

DMF 234402010

CADILA HEALTHCARE LTDInactiveDULOXETINE HYDROCHLORIDE USP (DUB ROUTE)

DMF 242742010

ESTEVE QUIMICA SAInactiveDULOXETINE HYDROCHLORIDE

DMF 246592011

JIANGSU HANSOH PHARMACEUTICAL CO LTDInactiveDULOXETINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 256252011

NOSCH LABS PRIVATE LTDInactiveDULOXETINE HYDROCHLORIDE, USP

DMF 267892013

SHODHANA LABORATORIES LTDInactiveDULOXETINE HYDROCHLORIDE USP

DMF 283982014

CTX LIFE SCIENCES PVT LTDInactiveDULOXETINE HYDROCHLORIDE USP

DMF 295402015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 13, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 20MG BASE

0 patents0 exclusivities▴

CAPSULE, DELAYED REL PELLETS;ORAL | Approved: Dec 11, 2013

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE

0 patents0 exclusivities▾

CAPSULE, DELAYED REL PELLETS;ORAL | Approved: Dec 11, 2013

#003 — EQ 60MG BASE

0 patents0 exclusivities▾

CAPSULE, DELAYED REL PELLETS;ORAL | Approved: Dec 11, 2013