Medicine
Lurasidone 80 mg tablet
Lurasidone 80 mg tablet is a generic prescription medicine for oral use, made by 20 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Lurasidone
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 blister pack, 30 tablets, 500 tablets and 54 more
- Manufacturers
- Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaDr. Reddy's LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAccord HealthcareIndiaAvet PharmaceuticalsIndiaCiplaIndia20 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° 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
- 3 January 2019
- Identifiers
- RxCUI 1040031, 1040041, 1235247 +2DailyMed set ID 2b07a830-93ba-427a-95fc-5138a6309f1e, 84648adf-b3c6-476e-8d11-2a9d7c5eb550, 76c055aa-d96a-42e5-a670-1db63b9c1dd6 +20NDC 33342-422, 53746-881, 69097-938 +20Application ANDA212124, ANDA208002, ANDA208028 +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 20 labelers. The register lists 57 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 46708-497-10 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 30 tablet, film coated in 1 bottle | 46708-497-30 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 500 tablet, film coated in 1 bottle | 46708-497-71 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 90 tablet, film coated in 1 bottle | 46708-497-90 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 1000 tablet, film coated in 1 bottle | 46708-497-91 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 62332-497-10 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 30 tablet, film coated in 1 bottle | 62332-497-30 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 500 tablet, film coated in 1 bottle | 62332-497-71 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 90 tablet, film coated in 1 bottle | 62332-497-90 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 1000 tablet, film coated in 1 bottle | 62332-497-91 | Alembic PharmaceuticalsIndia | 24 January 2023 |
| 100 tablet, coated in 1 bottle | 68382-967-01 | Zydus LifesciencesIndia | 1 February 2023 |
| 500 tablet, coated in 1 bottle | 68382-967-05 | Zydus LifesciencesIndia | 1 February 2023 |
| 30 tablet, coated in 1 bottle | 68382-967-06 | Zydus LifesciencesIndia | 1 February 2023 |
| 90 tablet, coated in 1 bottle | 68382-967-16 | Zydus LifesciencesIndia | 1 February 2023 |
| 100 blister pack in 1 carton / 1 tablet, coated in 1 blister pack | 68382-967-77 | Zydus LifesciencesIndia | 1 February 2023 |
| 100 tablet, coated in 1 bottle | 70771-1737-1 | Zydus LifesciencesIndia | 1 February 2023 |
| 30 tablet, coated in 1 bottle | 70771-1737-3 | Zydus LifesciencesIndia | 1 February 2023 |
| 10 blister pack in 1 carton / 10 tablet, coated in 1 blister pack | 70771-1737-4 | Zydus LifesciencesIndia | 1 February 2023 |
| 500 tablet, coated in 1 bottle | 70771-1737-5 | Zydus LifesciencesIndia | 1 February 2023 |
| 90 tablet, coated in 1 bottle | 70771-1737-9 | Zydus LifesciencesIndia | 1 February 2023 |
| 30 tablet, film coated in 1 bottle | 16729-349-10 | Accord HealthcareIndia | 20 February 2023 |
| 500 tablet, film coated in 1 bottle | 67877-641-05 | Ascend LaboratoriesIndia | 4 January 2023 |
| 30 tablet, film coated in 1 bottle | 67877-641-30 | Ascend LaboratoriesIndia | 4 January 2023 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-641-38 | Ascend LaboratoriesIndia | 4 January 2023 |
| 90 tablet, film coated in 1 bottle | 67877-641-90 | Ascend LaboratoriesIndia | 4 January 2023 |
| 500 tablet in 1 bottle | 65862-956-05 | Aurobindo PharmaIndia | 10 March 2023 |
| 30 tablet in 1 bottle | 65862-956-30 | Aurobindo PharmaIndia | 10 March 2023 |
| 90 tablet in 1 bottle | 65862-956-90 | Aurobindo PharmaIndia | 10 March 2023 |
| 30 tablet, film coated in 1 bottle | 23155-890-03 | Avet PharmaceuticalsIndia | 19 October 2023 |
| 500 tablet, film coated in 1 bottle | 31722-083-05 | Camber PharmaceuticalsIndia | 21 August 2024 |
| 30 tablet, film coated in 1 bottle | 31722-083-30 | Camber PharmaceuticalsIndia | 21 August 2024 |
| 90 tablet, film coated in 1 bottle | 31722-083-90 | Camber PharmaceuticalsIndia | 21 August 2024 |
| 30 tablet, film coated in 1 bottle | 69097-938-02 | CiplaIndia | 20 February 2023 |
| 500 tablet, film coated in 1 bottle | 43598-354-05 | Dr. Reddy's LaboratoriesIndia | 20 February 2023 |
| 30 tablet, film coated in 1 bottle | 43598-354-30 | Dr. Reddy's LaboratoriesIndia | 20 February 2023 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 43598-354-78 | Dr. Reddy's LaboratoriesIndia | 20 February 2023 |
| 90 tablet, film coated in 1 bottle | 43598-354-90 | Dr. Reddy's LaboratoriesIndia | 20 February 2023 |
| 30 tablet in 1 bottle | 68180-673-06 | LupinIndia | 20 February 2023 |
| 30 tablet, film coated in 1 bottle | 33342-422-07 | Macleods PharmaceuticalsIndia | 9 June 2023 |
| 90 tablet, film coated in 1 bottle | 33342-422-10 | Macleods PharmaceuticalsIndia | 9 June 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.
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 80 mg tablet.
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 LurasidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Latuda prescribing information (Sumitomo Pharma) · U.S. National Library of Medicine, DailyMed
- Latuda: European public assessment report (EPAR) · European Medicines Agency
Need Lurasidone 80 mg tablet for your hospital or patient?
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