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Active ingredient

Duloxetine

207 finished FDA listings contain Duloxetine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DULOXETINE, DULOXETINE HYDROCHLORIDE
Dosage forms
Capsule, Delayed Release, Capsule, Delayed Release Pellets
Routes
Oral
Manufacturers / labelers
48
Strengths listed
120 mg/1 · 20 mg/1 · 30 mg/1 · 40 mg/1 · 60 mg/1 · 80 mg/1 · 90 mg/1
Brand names in FDA listings
Cymbalta, Drizalma Sprinkle, Duloxetine, Duloxetine Delayed-Release, Duloxetine Dr, Duloxetine Hcl Dr, Duloxetine Hydrochloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 72625

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021427LILLY2004-08-033
ANDA 090694LUPIN2013-12-1137
ANDA 090723MARKSANS PHARMA2013-12-113
ANDA 090778AUROBINDO PHARMA LTD2013-12-118
ANDA 090745SUN PHARM2013-12-113
ANDA 090776ACTAVIS ELIZABETH2013-12-1715
ANDA 090739ZYDUS HLTHCARE2014-01-083
ANDA 202949ALEMBIC2014-06-096
ANDA 203088BRECKENRIDGE2014-06-1137
ANDA 203197ALKEM LABS LTD2015-08-266
ANDA 202336INVENTIA2015-10-286
ANDA 204343HETERO LABS LTD III2016-08-033
ANDA 208706AJANTA PHARMA LTD2017-01-0657
ANDA 204815MACLEODS PHARMS2017-03-233
ANDA 206653PRINSTON INC2017-05-184
ANDA 210599QINGDAO BAHEAL PHARM2019-04-173
NDA 212516SUN PHARM2019-07-194
ANDA 207219YAOPHARMA CO LTD2019-08-163
NDA 219131ALMATICA2026-02-273

Official labeling on DailyMed

Showing the 12 most recent of 131 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.