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Medicine

Lurasidone 60 mg tablet

Lurasidone · Oral
Available on requestPrescription onlyUS FDAGeneric name

Lurasidone 60 mg tablet is a generic prescription medicine for oral use, made by 22 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 lurasidone hydrochloride tablets at 25°C (77°F), excursions permitted to…

Key facts

Active ingredient (INN)
Lurasidone
Brand
Sold under the generic name
Strength
60 mg
Dosage form
Tablet
Route
Oral
Packs
100 blister pack, 30 tablets, 500 tablets and 59 more
Manufacturers
Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaTorrent PharmaceuticalsIndiaAvet PharmaceuticalsIndiaAccord HealthcareIndiaCiplaIndia22 labelers on the register
Origin register
US FDA, United States
Storage
Store lurasidone hydrochloride tablets at 25°C (77°F), excursions permitted to 15°C to 30°C (59° F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N05AE05 Lurasidone
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
4 September 2019
Identifiers
RxCUI 1040031, 1040041, 1235247 +2DailyMed set ID 7e11ec22-63c1-41a6-899c-4fe746f76bd0, 1cc441b3-0a23-4c68-a90e-436030b7daf2, b3e9cc86-0c5c-444f-ab57-f4d1a6865035 +24NDC 16729-348, 62332-496, 65862-955 +24Application ANDA208049, ANDA213248, ANDA208045 +12

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 22 labelers. The register lists 62 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack46708-496-10Alembic PharmaceuticalsIndia24 January 2023
30 tablet, film coated in 1 bottle46708-496-30Alembic PharmaceuticalsIndia24 January 2023
500 tablet, film coated in 1 bottle46708-496-71Alembic PharmaceuticalsIndia24 January 2023
90 tablet, film coated in 1 bottle46708-496-90Alembic PharmaceuticalsIndia24 January 2023
1000 tablet, film coated in 1 bottle46708-496-91Alembic PharmaceuticalsIndia24 January 2023
100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack62332-496-10Alembic PharmaceuticalsIndia24 January 2023
30 tablet, film coated in 1 bottle62332-496-30Alembic PharmaceuticalsIndia24 January 2023
500 tablet, film coated in 1 bottle62332-496-71Alembic PharmaceuticalsIndia24 January 2023
90 tablet, film coated in 1 bottle62332-496-90Alembic PharmaceuticalsIndia24 January 2023
1000 tablet, film coated in 1 bottle62332-496-91Alembic PharmaceuticalsIndia24 January 2023
30 tablet, film coated in 1 bottle13668-509-30Torrent PharmaceuticalsIndia17 February 2023
30 tablet, film coated in 1 bottle13668-737-30Torrent PharmaceuticalsIndia2 March 2026
90 tablet, film coated in 1 bottle13668-737-90Torrent PharmaceuticalsIndia2 March 2026
100 tablet, coated in 1 bottle68382-859-01Zydus LifesciencesIndia1 February 2023
500 tablet, coated in 1 bottle68382-859-05Zydus LifesciencesIndia1 February 2023
30 tablet, coated in 1 bottle68382-859-06Zydus LifesciencesIndia1 February 2023
90 tablet, coated in 1 bottle68382-859-16Zydus LifesciencesIndia1 February 2023
100 blister pack in 1 carton / 1 tablet, coated in 1 blister pack68382-859-77Zydus LifesciencesIndia1 February 2023
100 tablet, coated in 1 bottle70771-1736-1Zydus LifesciencesIndia1 February 2023
30 tablet, coated in 1 bottle70771-1736-3Zydus LifesciencesIndia1 February 2023
10 blister pack in 1 carton / 10 tablet, coated in 1 blister pack70771-1736-4Zydus LifesciencesIndia1 February 2023
500 tablet, coated in 1 bottle70771-1736-5Zydus LifesciencesIndia1 February 2023
90 tablet, coated in 1 bottle70771-1736-9Zydus LifesciencesIndia1 February 2023
30 tablet, film coated in 1 bottle16729-348-10Accord HealthcareIndia20 February 2023
500 tablet, film coated in 1 bottle67877-640-05Ascend LaboratoriesIndia4 January 2023
30 tablet, film coated in 1 bottle67877-640-30Ascend LaboratoriesIndia4 January 2023
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack67877-640-38Ascend LaboratoriesIndia4 January 2023
90 tablet, film coated in 1 bottle67877-640-90Ascend LaboratoriesIndia4 January 2023
500 tablet in 1 bottle65862-955-05Aurobindo PharmaIndia10 March 2023
30 tablet in 1 bottle65862-955-30Aurobindo PharmaIndia10 March 2023
90 tablet in 1 bottle65862-955-90Aurobindo PharmaIndia10 March 2023
30 tablet, film coated in 1 bottle23155-889-03Avet PharmaceuticalsIndia19 October 2023
40000 tablet, film coated in 1 container23155-889-18Avet PharmaceuticalsIndia19 October 2023
500 tablet, film coated in 1 bottle31722-082-05Camber PharmaceuticalsIndia21 August 2024
30 tablet, film coated in 1 bottle31722-082-30Camber PharmaceuticalsIndia21 August 2024
90 tablet, film coated in 1 bottle31722-082-90Camber PharmaceuticalsIndia21 August 2024
30 tablet, film coated in 1 bottle69097-939-02CiplaIndia20 February 2023
500 tablet, film coated in 1 bottle43598-353-05Dr. Reddy's LaboratoriesIndia20 February 2023
30 tablet, film coated in 1 bottle43598-353-30Dr. Reddy's LaboratoriesIndia20 February 2023
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack43598-353-78Dr. Reddy's LaboratoriesIndia20 February 2023

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 28 October 2010Drugs@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 Lurasidone 60 mg tablet.

Compare 1

Other strengths and forms of Lurasidone

Clinical summary

Lurasidone is an atypical antipsychotic indicated for treatment of adult and adolescent patients (13 to 17 years) with schizophrenia. It is available as tablets for oral use. MedsAcross supplies Lurasidone 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 Lurasidone

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

Data sources

Need Lurasidone 60 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.