FDA.reportPublic FDA data

DULOXETINE HYDROCHLORIDE

Substance profile for UNII 9044SC542W, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for DULOXETINE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Substance Identity#

UNII
9044SC542W
Preferred term
DULOXETINE HYDROCHLORIDE
Registry number
136434-34-9
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C18H19NOS.ClH
Chemical structure for DULOXETINE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Chemical And Database Identifiers#

InChIKey
BFFSMCNJSOPUAY-LMOVPXPDSA-N
SMILES
Cl.CNCC[C@H](OC1=C2C=CC=CC2=CC=C1)C3=CC=CS3
RxCUI
476250
PubChem
0
NCIt
C65496
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem InChIKey SearchBFFSMCNJSOPUAY-LMOVPXPDSA-Nhttps://pubchem.ncbi.nlm.nih.gov/#query=BFFSMCNJSOPUAY-LMOVPXPDSA-N
RxNorm476250https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=476250
NCI ThesaurusC65496https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C65496
FDA Substance Registration System9044SC542Whttps://precision.fda.gov/uniisearch/srs/unii/9044SC542W

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use duloxetine delayed-release capsules, USP safely and effectively. See full prescribing information for duloxetine delayed-release capsules, USP. DULOXETINE delayed-release capsules USP, for oral use. Initial U.S. Approval: 20042
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use duloxetine delayed-release capsules USP safely and effectively. See full prescribing information for duloxetine delayed-release capsules USP. DULOXETINE delayed-release capsules USP for oral use Initial U.S. Approval: 20042
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use Duloxetine Delayed-release Capsules safely and effectively. See full prescribing information for Duloxetine Delayed-release Capsules. DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 20042
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 20041
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use CYMBALTA safely and effectively. See full prescribing information for CYMBALTA. CYMBALTA (Duloxetine Delayed-Release Capsules) for Oral Use. Initial U.S. Approval: 20042
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use duloxetine delayed-release capsules, USP safely and effectively. See full prescribing information for duloxetine delayed-release capsules, USP . DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 20041
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use duloxetine safely and effectively. See full prescribing information for duloxetine. Duloxetine Delayed-Release Capsules for Oral Use. Initial U.S. Approval: 20042
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use Cymbalta safely and effectively. See full prescribing information for Cymbalta. Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use. Initial U.S. Approval: 20041
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use Cymbalta safely and effectively. See full prescribing information for Cymbalta. Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use. Initial U.S. Approval: 20041
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use Cymbalta safely and effectively. See full prescribing information for Cymbalta. Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use. Initial U.S. Approval: 20041
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WThese highlights do not include all the information needed to use CYMBALTA safely and effectively. See full prescribing information for CYMBALTA. CYMBALTA (duloxetine hydrochloride) capsule, delayed release for oral use Initial U.S. Approval: 20041
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CYMBALTA safely and effectively. See full prescribing information for CYMBALTA. CYMBALTA (duloxetine hydrochloride) capsule, delayed release for oral use Initial U.S. Approval: 20041
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [LAKE ERIE MEDICAL SURGICAL & SUPPLY DBA QUALITY CARE PRODUCTS LLC]3388
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WCYMBALTA (CYMBALTA) CAPSULE, DELAYED RELEASE [REMEDYREPACK INC. ]169
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]46
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]45
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [DR. REDDY'S LABORATORIES LIMITED]9
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE ) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE ) CAPSULE, DELAYED RELEASE [APOTEX CORP.]7
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]6
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [TRIGEN LABORATORIES, LLC]6
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]5
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES]5
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]4
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]4
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]3
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]2
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]2
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES]2
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE]1
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REMEDYREPACK INC. ]1
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ST MARYS MEDICAL PARK PHARMACY]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [KAISER FOUNDATION HOSPITALS]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC. ]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC. ]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC. ]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [PREFERRED PHARMACEUTICALS, INC.]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PREFERRED PHARMACEUTICALS, INC.]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]1
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WIRENKA (DULOXETINE) CAPSULE, DELAYED RELEASE [LUPIN PHARMA]1