Skip to content
LookupMeds

Active ingredient

Quetiapine

349 finished FDA listings contain Quetiapine as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
QUETIAPINE, QUETIAPINE FUMARATE
Dosage forms
Tablet, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
52
Strengths listed
100 mg/1 · 150 mg/1 · 200 mg/1 · 25 mg/1 · 300 mg/1 · 400 mg/1 · 50 mg/1
Brand names in FDA listings
Quetiapine Extended Release, Quetiapine Extended-Release, Quetiapine Fumarate, Seroquel, Seroquel Xr

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 51272

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 020639CHEPLAPHARM1997-09-2612
NDA 022047CHEPLAPHARM2007-05-179
ANDA 091388AUROBINDO PHARMA LTD2012-03-2738
ANDA 090120HIKMA2012-03-273
ANDA 077745TEVA PHARMS2012-03-279
ANDA 090749HIKMA2012-03-2714
ANDA 201190SUN PHARM2012-03-2710
ANDA 202152ACCORD HLTHCARE2012-03-2714
ANDA 201109LUPIN LTD2012-03-2750
ANDA 201504ALKEM LABS LTD2013-02-1255
ANDA 203390ALEMBIC2014-10-286
ANDA 202674UNICHEM2016-03-0820
ANDA 203359MACLEODS PHARMS2016-05-177
ANDA 090681ACCORD HLTHCARE2016-11-017
ANDA 204203LUPIN2017-05-1710
ANDA 206252ACCORD HLTHCARE2017-11-291
ANDA 209635SCIEGEN PHARMS2017-11-2920
ANDA 208947NOVAST LABS2017-11-299
ANDA 207655AUROBINDO PHARMA2017-11-295
ANDA 204253MACLEODS PHARMS2017-11-298
ANDA 209497ALIGNSCIENCE PHARMA2018-09-282
ANDA 208781PRINSTON INC2022-04-265
ANDA 204316HETERO LABS LTD V2022-06-1615
ANDA 215478UNICHEM2022-08-1514
ANDA 206954PRINSTON INC2022-08-246

Official labeling on DailyMed

Showing the 12 most recent of 148 labels.

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