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Active ingredient

Sertraline

225 finished FDA listings contain Sertraline as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
SERTRALINE, SERTRALINE HYDROCHLORIDE
Dosage forms
Capsule, Solution, Solution, Concentrate, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
52
Strengths listed
100 mg/1 · 150 mg/1 · 20 mg/ml · 200 mg/1 · 25 mg/1 · 50 mg/1
Brand names in FDA listings
Sertraline, Sertraline Hcl, Zoloft

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 36437

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 019839VIATRIS1991-12-303
NDA 020990VIATRIS1999-12-072
ANDA 076934STRIDES PHARMA2006-06-301
ANDA 076465HERITAGE2006-08-1111
ANDA 077206AUROBINDO PHARMA2007-02-0661
ANDA 077670LUPIN2007-02-0652
ANDA 077397INVAGEN PHARMS2007-02-0627
ANDA 076442SCIEGEN PHARMS2007-04-303
ANDA 078403GRANULES2008-01-0815
ANDA 078861AUROBINDO PHARMA2008-10-313
ANDA 202825ACCORD HLTHCARE2014-11-0713
ANDA 214790ASCENT PHARMS INC2021-05-0314
NDA 215133ALMATICA2021-10-044
ANDA 218853ZENARA2025-07-162
ANDA 218712APPCO2026-01-202
ANDA 218342UMEDICA2026-01-204
ANDA 219714NOVITIUM PHARMA2026-01-202
ANDA 219655AMNEAL2026-01-282
ANDA 220275ZYDUS LIFESCIENCES2026-01-294

Official labeling on DailyMed

Showing the 12 most recent of 158 labels.

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