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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020592 | CHEPLAPHARM | 1996-09-30 | 6 |
| NDA 021086 | CHEPLAPHARM | 2000-04-06 | 4 |
| NDA 021253 | CHEPLAPHARM | 2004-03-29 | 1 |
| ANDA 076534 | DR REDDYS LABS LTD | 2011-10-24 | 4 |
| ANDA 078109 | STRIDES PHARMA INTL | 2011-10-24 | 4 |
| ANDA 076133 | DR REDDYS LABS LTD | 2011-10-24 | 9 |
| ANDA 201588 | SANDOZ INC | 2011-10-24 | 2 |
| ANDA 091265 | APOTEX INC | 2011-10-24 | 13 |
| ANDA 091415 | TORRENT | 2011-10-25 | 4 |
| ANDA 077243 | BARR LABS INC | 2012-01-30 | 4 |
| ANDA 201741 | AM REGENT | 2012-03-20 | 1 |
| ANDA 076255 | DR REDDYS LABS LTD | 2012-04-23 | 26 |
| ANDA 090798 | APOTEX INC | 2012-04-23 | 21 |
| ANDA 091434 | TORRENT PHARMS LTD | 2012-04-23 | 6 |
| ANDA 202050 | AUROBINDO PHARMA LTD | 2012-04-23 | 7 |
| ANDA 200221 | JUBILANT GENERICS | 2012-09-12 | 4 |
| ANDA 203708 | AUROBINDO PHARMA LTD | 2014-05-15 | 4 |
| ANDA 202862 | MACLEODS PHARMS LTD | 2014-08-15 | 39 |
| ANDA 203044 | MACLEODS PHARMS | 2015-02-20 | 4 |
| ANDA 202937 | ORBION PHARMS | 2015-03-02 | 4 |
| ANDA 202295 | ALKEM LABS LTD | 2015-10-20 | 6 |
| ANDA 204319 | QILU | 2016-01-27 | 6 |
| ANDA 208146 | HEC PHARM | 2018-07-03 | 8 |
| ANDA 206238 | SUNSHINE | 2018-11-19 | 6 |
| ANDA 210968 | EUGIA PHARMA | 2020-10-22 | 1 |
| ANDA 210022 | CADILA PHARMS LTD | 2023-02-24 | 16 |
| ANDA 217466 | ASPIRO | 2023-03-22 | 2 |
| ANDA 218116 | QILU | 2025-05-16 | 2 |
| ANDA 211072 | UBI | 2025-06-11 | 3 |
| ANDA 220323 | ADAPTIS | 2026-03-05 | 2 |
Official labeling on DailyMed
- OLANZAPINE TABLET, FILM COATED [COUPLER LLC] · version 1 · 2026-09-10
- OLANZAPINE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 4 · 2026-08-26
- OLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 15 · 2026-08-25
- OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-08-20
- OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 15 · 2026-08-10
- OLANZAPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-07
- OLANZAPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 8 · 2026-08-07
- OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 10 · 2026-07-24
- OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 10 · 2026-07-24
- OLANZAPINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 15 · 2026-07-21
- OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 14 · 2026-07-15
- OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 13 · 2026-07-13
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.