Medicine
Risperidone 1 mg/mL oral solution
Risperidone 1 mg/mL oral solution is a generic prescription medicine for oral use, made by 10 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 in carton, away from direct sunlight.
Key facts
- Active ingredient (INN)
- Risperidone
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 30 mL, 10 cup and 19 more
- Manufacturers
- Aurobindo PharmaIndiaAtlantic BiologicalsBryant Ranch PrepackRemedyrepackAmneal PharmaceuticalsANI PharmaceuticalsApozeal PharmaceuticalsChartwell RXCranbury PharmaceuticalsJanssen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store in carton, away from direct sunlight.
- 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 1996
- Identifiers
- RxCUI 199387, 312829, 312830 +7DailyMed set ID 3cc027f0-3462-4a2f-925b-d8a529bcb3c3, dc8c6638-f487-49df-a265-78caa93e43d8, bc55f60a-8121-44bb-bdfc-1d311879ba4f +9NDC 72162-2037, 17856-1002, 65162-673 +9Application ANDA079059, ANDA091384, ANDA202386 +4
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 30 mL in 1 bottle | 65862-167-01 | Aurobindo PharmaIndia | 25 March 2019 |
| 1 bottle, glass in 1 carton / 30 mL in 1 bottle, glass | 65862-167-30 | Aurobindo PharmaIndia | 25 March 2019 |
| 30 mL in 1 bottle | 65162-673-84 | Amneal Pharmaceuticals | 31 May 2011 |
| 30 mL in 1 bottle | 62559-981-30 | ANI Pharmaceuticals | 27 October 2025 |
| 30 mL in 1 bottle | 83745-186-30 | Apozeal Pharmaceuticals | 31 January 2025 |
| 30 mL in 1 bottle | 62135-929-43 | Chartwell RX | 28 July 2022 |
| 30 mL in 1 bottle, unit-dose | 27808-002-01 | Cranbury Pharmaceuticals | 13 March 2015 |
| 30 mL in 1 bottle | 50458-596-01 | Janssen Pharmaceuticals | 10 June 1996 |
| 30 mL in 1 bottle | 71335-2733-1 | Bryant Ranch Prepack | 29 July 2025 |
| 30 mL in 1 bottle | 72162-2037-2 | Bryant Ranch Prepack | 6 June 2023 |
| 30 mL in 1 bottle | 72162-2037-3 | Bryant Ranch Prepack | 6 June 2023 |
| 10 cup, unit-dose in 1 box / 2 mL in 1 cup, unit-dose | 70518-3741-0 | Remedyrepack | 1 June 2023 |
| 10 cup, unit-dose in 1 box / 2 mL in 1 cup, unit-dose | 70518-3760-0 | Remedyrepack | 12 June 2023 |
| 120 syringe in 1 box, unit-dose / 1 mL in 1 syringe | 17856-1002-1 | Atlantic Biologicals | 19 September 2024 |
| 120 syringe in 1 box, unit-dose / 1 mL in 1 syringe | 17856-1002-2 | Atlantic Biologicals | 19 September 2024 |
| 120 syringe in 1 box, unit-dose / 2 mL in 1 syringe | 17856-1002-3 | Atlantic Biologicals | 19 September 2024 |
| 120 syringe in 1 box, unit-dose / 3 mL in 1 syringe | 17856-1002-4 | Atlantic Biologicals | 19 September 2024 |
| 120 syringe in 1 box, unit-dose / 2 mL in 1 syringe | 17856-1002-5 | Atlantic Biologicals | 10 July 2026 |
| 48 syringe in 1 box, unit-dose / 3 mL in 1 syringe | 17856-1002-6 | Atlantic Biologicals | 14 October 2026 |
| 48 syringe in 1 box, unit-dose / 3 mL in 1 syringe | 17856-1002-7 | Atlantic Biologicals | 14 October 2026 |
| 48 syringe in 1 box, unit-dose / 4 mL in 1 syringe | 17856-1002-8 | Atlantic Biologicals | 14 October 2026 |
| 48 syringe in 1 box, unit-dose / 4 mL in 1 syringe | 17856-1002-9 | Atlantic Biologicals | 14 October 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.
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 1 mg/mL oral solution.
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 1 mg/mL oral solution for your hospital or patient?
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