Medicine
Risperidone 4 mg orally disintegrating tablet
Risperidone 4 mg orally disintegrating tablet is a generic prescription medicine for oral use, made by 5 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 Orally Disintegrating Tablets, USP should be stored at 20° to 25°C…
Key facts
- Active ingredient (INN)
- Risperidone
- Brand
- Sold under the generic name
- Strength
- 4 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 7 blister pack, 500 tablets, 1 pouch and 5 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaJubilant Cadista PharmaceuticalsIndiaAmerisynAmici PharmaPar Health
- Origin register
- US FDA, United States
- Storage
- Risperidone Orally Disintegrating Tablets, USP should be stored at 20° to 25°C (68° to 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
- 10 June 2009
- Identifiers
- RxCUI 401953, 401954, 403825 +3DailyMed set ID d0ef6df3-67e5-47b1-bcf7-f67aa030caca, ca41c144-224a-4d57-88d7-8778e6c69ed2, 58b7504f-c4a3-ef1b-e063-6394a90ac0f3 +2NDC 49884-403, 69292-575, 87564-017 +2Application ANDA077494, ANDA077328, ANDA090839 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 7 blister pack in 1 carton / 4 tablet, orally disintegrating in 1 blister pack | 59746-050-22 | Jubilant Cadista PharmacuticalsIndia | 4 November 2011 |
| 500 tablet, orally disintegrating in 1 bottle | 63304-644-05 | Sun Pharmaceutical IndustriesIndia | 6 August 2010 |
| 1 pouch in 1 box, unit-dose / 1 tablet, orally disintegrating in 1 pouch | 63304-644-17 | Sun Pharmaceutical IndustriesIndia | 6 August 2010 |
| 30 tablet, orally disintegrating in 1 bottle | 63304-644-30 | Sun Pharmaceutical IndustriesIndia | 6 August 2010 |
| 1 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 63304-644-69 | Sun Pharmaceutical IndustriesIndia | 6 August 2010 |
| 4 tablet, orally disintegrating in 1 blister pack | 87564-017-28 | Amerisyn | 6 August 2026 |
| 7 blister pack in 1 carton / 4 tablet, orally disintegrating in 1 blister pack | 69292-575-28 | Amici Pharma | 1 April 2026 |
| 7 blister pack in 1 carton / 4 tablet, orally disintegrating in 1 blister pack | 49884-403-91 | Par Health | 10 June 2009 |
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 4 mg orally disintegrating 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 4 mg orally disintegrating tablet for your hospital or patient?
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