Medicine
Risperidone 0.5 mg tablet
Risperidone 0.5 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Risperidone Tablets should be stored at controlled room temperature 15°-25°C…
Key facts
- Active ingredient (INN)
- Risperidone
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 43 more
- Manufacturers
- Zydus LifesciencesIndiaTorrent PharmaceuticalsIndiaAjanta PharmaIndiaJubilant Cadista PharmaceuticalsIndiaBryant Ranch PrepackAmneal Pharmaceuticals NYAvKAREProficient RxSolco HealthcareA-S Medication Solutions19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Risperidone Tablets should be stored at controlled room temperature 15°-25°C (59°-77°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05AX08 Risperidone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 13 November 2008
- Identifiers
- RxCUI 312828, 312829, 312830 +3DailyMed set ID 7bbc37f1-6d6a-4021-8976-1f103ce1cfbd, 448467a3-44ef-c87b-e063-6294a90a5ec9, 12a479c4-a84a-4308-b89f-be0315826fd5 +17NDC 0615-8197, 84677-003, 62135-601 +17Application ANDA077493, ANDA078828, ANDA077543 +5
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 46 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65841-666-01 | Zydus LifesciencesIndia | 13 November 2008 |
| 500 tablet, film coated in 1 bottle | 65841-666-05 | Zydus LifesciencesIndia | 13 November 2008 |
| 30 tablet, film coated in 1 bottle | 65841-666-06 | Zydus LifesciencesIndia | 13 November 2008 |
| 1000 tablet, film coated in 1 bottle | 65841-666-10 | Zydus LifesciencesIndia | 13 November 2008 |
| 60 tablet, film coated in 1 bottle | 65841-666-14 | Zydus LifesciencesIndia | 13 November 2008 |
| 90 tablet, film coated in 1 bottle | 65841-666-16 | Zydus LifesciencesIndia | 13 November 2008 |
| 100 tablet, film coated in 1 bottle | 68382-113-01 | Zydus LifesciencesIndia | 13 November 2008 |
| 500 tablet, film coated in 1 bottle | 68382-113-05 | Zydus LifesciencesIndia | 13 November 2008 |
| 30 tablet, film coated in 1 bottle | 68382-113-06 | Zydus LifesciencesIndia | 13 November 2008 |
| 1000 tablet, film coated in 1 bottle | 68382-113-10 | Zydus LifesciencesIndia | 13 November 2008 |
| 60 tablet, film coated in 1 bottle | 68382-113-14 | Zydus LifesciencesIndia | 13 November 2008 |
| 90 tablet, film coated in 1 bottle | 68382-113-16 | Zydus LifesciencesIndia | 13 November 2008 |
| 60 tablet in 1 bottle | 27241-003-06 | Ajanta PharmaIndia | 28 March 2014 |
| 500 tablet in 1 bottle | 27241-003-50 | Ajanta PharmaIndia | 28 March 2014 |
| 500 tablet in 1 bottle | 59746-222-05 | Jubilant Cadista PharmacuticalsIndia | 15 October 2025 |
| 60 tablet in 1 bottle | 59746-222-60 | Jubilant Cadista PharmacuticalsIndia | 15 October 2025 |
| 100 tablet in 1 bottle | 13668-036-01 | Torrent PharmaceuticalsIndia | 1 January 2009 |
| 500 tablet in 1 bottle | 13668-036-05 | Torrent PharmaceuticalsIndia | 1 January 2009 |
| 30 tablet in 1 bottle | 13668-036-30 | Torrent PharmaceuticalsIndia | 1 January 2009 |
| 8500 tablet in 1 bottle | 13668-036-54 | Torrent PharmaceuticalsIndia | 1 January 2009 |
| 60 tablet in 1 bottle | 13668-036-60 | Torrent PharmaceuticalsIndia | 1 January 2009 |
| 500 tablet in 1 blister pack | 69238-2109-5 | Amneal Pharmaceuticals NY | 1 August 2021 |
| 60 tablet in 1 bottle | 69238-2109-6 | Amneal Pharmaceuticals NY | 1 August 2021 |
| 60 tablet, film coated in 1 bottle | 62135-601-60 | Chartwell RX | 29 December 2023 |
| 60 tablet in 1 bottle | 43547-340-06 | Solco Healthcare | 1 June 2014 |
| 500 tablet in 1 bottle | 43547-340-50 | Solco Healthcare | 1 June 2014 |
| 30 tablet in 1 bottle | 50090-3344-0 | A-S Medication Solutions | 22 January 2018 |
| 100 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 68084-271-01 | American Health Packaging | 2 December 2008 |
| 500 tablet, film coated in 1 bottle | 42291-975-50 | AvKARE | 6 March 2025 |
| 60 tablet, film coated in 1 bottle | 42291-975-60 | AvKARE | 6 March 2025 |
| 60 tablet in 1 bottle | 71335-0130-1 | Bryant Ranch Prepack | 14 December 2018 |
| 30 tablet in 1 bottle | 71335-0130-2 | Bryant Ranch Prepack | 17 September 2018 |
| 90 tablet in 1 bottle | 71335-0130-3 | Bryant Ranch Prepack | 22 January 2019 |
| 120 tablet in 1 bottle | 71335-0130-4 | Bryant Ranch Prepack | 29 May 2024 |
| 10 blister pack in 1 bag / 1 tablet, film coated in 1 blister pack | 55154-0180-0 | Cardinal Health | 19 May 2025 |
| 30 tablet in 1 blister pack | 67046-0644-3 | Coupler | 10 July 2026 |
| 500 tablet in 1 bottle | 84677-003-05 | Golden State Medical Supply | 26 September 2025 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0904-7361-61 | Major Pharmaceuticals | 27 October 2023 |
| 30 tablet in 1 bottle | 63187-642-30 | Proficient Rx | 1 December 2018 |
| 60 tablet in 1 bottle | 63187-642-60 | Proficient Rx | 1 December 2018 |
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 Risperidone 0.5 mg tablet.
Other strengths and forms of Risperidone
Clinical summary
Risperidone is an atypical antipsychotic indicated for treatment of schizophrenia, among other approved uses. It is available as tablets, orally disintegrating tablets and oral solution for subcutaneous use. MedsAcross supplies Risperidone 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 RisperidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RISPERDAL prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Okedi: European public assessment report (EPAR) · European Medicines Agency
Need Risperidone 0.5 mg tablet for your hospital or patient?
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