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Active ingredient

Olanzapine

219 finished FDA listings contain Olanzapine as their only active ingredient; 19 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
OLANZAPINE, OLANZAPINE PAMOATE
Dosage forms
Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Intramuscular, Oral
Manufacturers / labelers
44
Strengths listed
10 mg/1 · 10 mg/2ml · 15 mg/1 · 2.5 mg/1 · 20 mg/1 · 5 mg/1 · 7.5 mg/1
Brand names in FDA listings
Olanzapine Intramuscular, Zyprexa, Zyprexa Intramuscular, Zyprexa Zydis

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 61381

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 020592CHEPLAPHARM1996-09-306
NDA 021086CHEPLAPHARM2000-04-064
NDA 021253CHEPLAPHARM2004-03-291
ANDA 076534DR REDDYS LABS LTD2011-10-244
ANDA 078109STRIDES PHARMA INTL2011-10-244
ANDA 076133DR REDDYS LABS LTD2011-10-249
ANDA 201588SANDOZ INC2011-10-242
ANDA 091265APOTEX INC2011-10-2413
ANDA 091415TORRENT2011-10-254
ANDA 077243BARR LABS INC2012-01-304
ANDA 201741AM REGENT2012-03-201
ANDA 076255DR REDDYS LABS LTD2012-04-2326
ANDA 090798APOTEX INC2012-04-2321
ANDA 091434TORRENT PHARMS LTD2012-04-236
ANDA 202050AUROBINDO PHARMA LTD2012-04-237
ANDA 200221JUBILANT GENERICS2012-09-124
ANDA 203708AUROBINDO PHARMA LTD2014-05-154
ANDA 202862MACLEODS PHARMS LTD2014-08-1539
ANDA 203044MACLEODS PHARMS2015-02-204
ANDA 202937ORBION PHARMS2015-03-024
ANDA 202295ALKEM LABS LTD2015-10-206
ANDA 204319QILU2016-01-276
ANDA 208146HEC PHARM2018-07-038
ANDA 206238SUNSHINE2018-11-196
ANDA 210968EUGIA PHARMA2020-10-221
ANDA 210022CADILA PHARMS LTD2023-02-2416
ANDA 217466ASPIRO2023-03-222
ANDA 218116QILU2025-05-162
ANDA 211072UBI2025-06-113
ANDA 220323ADAPTIS2026-03-052

Official labeling on DailyMed

Showing the 12 most recent of 96 labels.

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