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Medicine

Olanzapine 20 mg tablet

Olanzapine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Olanzapine 20 mg tablet is a generic prescription medicine for oral use, made by 19 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store olanzapine tablets at controlled room temperature, 20° to 25°C (68° to…

Key facts

Active ingredient (INN)
Olanzapine
Brand
Sold under the generic name
Strength
20 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 1000 tablets, 30 tablets and 52 more
Manufacturers
Ascend LaboratoriesIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaMacleods PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaCadila PharmaceuticalsIndiaModavar PharmaceuticalsApotexCouplerHEC Pharm19 labelers on the register
Origin register
US FDA, United States
Storage
Store olanzapine tablets at controlled room temperature, 20° to 25°C (68° to 77°F). The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F), that results in a mean kinetic temperature calculated to be not more than 25°C, and that allows for excursions between 15° and 30°C…
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N05AH03 Olanzapine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 January 2012
Identifiers
RxCUI 200034, 283639, 312077 +7DailyMed set ID 6077f5c4-01d7-4c1d-97a0-cb859f98ce68, 2cb1bebe-0ced-46d8-bf21-c28a9acc4a15, a4c525da-c2f6-b804-af49-601295922254 +19NDC 67184-0566, 13668-171, 55111-168 +19Application ANDA204319, ANDA091434, ANDA076133 +6

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

A sample of 40 packs from 19 labelers. The register lists 55 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 bottle67877-177-01Ascend LaboratoriesIndia1 January 2012
1000 tablet in 1 bottle67877-177-10Ascend LaboratoriesIndia1 January 2012
30 tablet in 1 bottle67877-177-30Ascend LaboratoriesIndia1 January 2012
10 blister pack in 1 carton / 10 tablet in 1 blister pack67877-177-35Ascend LaboratoriesIndia1 January 2012
7 tablet in 1 bottle67877-177-37Ascend LaboratoriesIndia1 January 2012
3 blister pack in 1 carton / 10 tablet in 1 blister pack67877-177-85Ascend LaboratoriesIndia1 January 2012
100 tablet in 1 bottle65862-566-01Aurobindo PharmaIndia23 April 2012
500 tablet in 1 bottle65862-566-05Aurobindo PharmaIndia23 April 2012
10 blister pack in 1 carton / 10 tablet in 1 blister pack65862-566-10Aurobindo PharmaIndia23 April 2012
30 tablet in 1 bottle65862-566-30Aurobindo PharmaIndia23 April 2012
1000 tablet in 1 bottle65862-566-99Aurobindo PharmaIndia23 April 2012
30 tablet in 1 bottle71209-078-01Cadila PharmaceuticalsIndia13 February 2019
100 tablet in 1 bottle71209-078-05Cadila PharmaceuticalsIndia4 October 2023
500 tablet in 1 bottle71209-078-10Cadila PharmaceuticalsIndia4 October 2023
1000 tablet in 1 bottle71209-078-11Cadila PharmaceuticalsIndia13 February 2019
100 tablet, film coated in 1 bottle55111-168-01Dr. Reddy's LaboratoriesIndia23 April 2012
500 tablet, film coated in 1 bottle55111-168-05Dr. Reddy's LaboratoriesIndia23 April 2012
30 tablet, film coated in 1 bottle55111-168-30Dr. Reddy's LaboratoriesIndia23 April 2012
60 tablet, film coated in 1 bottle55111-168-60Dr. Reddy's LaboratoriesIndia23 April 2012
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack55111-168-78Dr. Reddy's LaboratoriesIndia23 April 2012
30 tablet, film coated in 1 bottle33342-072-07Macleods PharmaceuticalsIndia22 August 2014
100 tablet, film coated in 1 bottle33342-072-11Macleods PharmaceuticalsIndia22 August 2014
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack33342-072-12Macleods PharmaceuticalsIndia22 August 2014
500 tablet, film coated in 1 bottle33342-072-15Macleods PharmaceuticalsIndia22 August 2014
1000 tablet, film coated in 1 bottle33342-072-44Macleods PharmaceuticalsIndia22 August 2014
100 tablet in 1 bottle13668-171-01Torrent PharmaceuticalsIndia28 February 2026
500 tablet in 1 bottle13668-171-05Torrent PharmaceuticalsIndia28 February 2026
1000 tablet in 1 bottle13668-171-10Torrent PharmaceuticalsIndia28 February 2026
30 tablet in 1 bottle13668-171-30Torrent PharmaceuticalsIndia28 February 2026
60 tablet in 1 bottle13668-171-60Torrent PharmaceuticalsIndia28 February 2026
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack60505-3140-0Apotex23 April 2012
30 tablet, film coated in 1 bottle60505-3140-3Apotex23 April 2012
1000 tablet, film coated in 1 bottle60505-3140-8Apotex23 April 2012
30 tablet in 1 bottle, plastic72303-0840-1HEC Pharm30 November 2018
100 tablet in 1 bottle72241-056-04Modavar Pharmaceuticals17 January 2024
500 tablet in 1 bottle72241-056-10Modavar Pharmaceuticals17 January 2024
1000 tablet in 1 bottle72241-056-11Modavar Pharmaceuticals17 January 2024
30 tablet in 1 bottle72241-056-22Modavar Pharmaceuticals17 January 2024
30 tablet, film coated in 1 blister pack67046-0072-3Coupler19 June 2026
30 tablet, film coated in 1 blister pack67046-0524-3Coupler13 May 2026

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 September 1996Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Olanzapine 20 mg tablet.

Compare 1

Other strengths and forms of Olanzapine

Clinical summary

Olanzapine is an atypical antipsychotic indicated for the treatment of schizophrenia, among other approved uses. It is available as tablets, orally disintegrating tablets and powder for injection for intramuscular and subcutaneous use. MedsAcross supplies Olanzapine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Olanzapine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Olanzapine 20 mg tablet for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.