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Medicine

Risperidone 1 mg tablet

Risperidone · Oral
Available on requestPrescription onlyUS FDAGeneric name

Risperidone 1 mg tablet is a generic prescription medicine for oral use, made by 21 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

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
1 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 30 tablets and 53 more
Manufacturers
Zydus LifesciencesIndiaTorrent PharmaceuticalsIndiaAjanta PharmaIndiaJubilant Cadista PharmaceuticalsIndiaRemedyrepackPD-Rx PharmaceuticalsA-S Medication SolutionsAmneal Pharmaceuticals NYSolco HealthcareAmerican Health Packaging21 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).
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 312830, 312828, 312829 +3DailyMed set ID 390904c2-fcfa-466e-e063-6394a90a03af, 52bb35ac-1f7d-bfbe-e063-6294a90aa2b9, e72a2768-815f-47bf-b2f9-16a93dd10684 +21NDC 68071-3873, 67046-0635, 43063-254 +21Application ANDA077493, ANDA201003, ANDA079088 +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 21 labelers. The register lists 56 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, film coated in 1 bottle65841-667-01Zydus LifesciencesIndia13 November 2008
500 tablet, film coated in 1 bottle65841-667-05Zydus LifesciencesIndia13 November 2008
30 tablet, film coated in 1 bottle65841-667-06Zydus LifesciencesIndia13 November 2008
1000 tablet, film coated in 1 bottle65841-667-10Zydus LifesciencesIndia13 November 2008
60 tablet, film coated in 1 bottle65841-667-14Zydus LifesciencesIndia13 November 2008
90 tablet, film coated in 1 bottle65841-667-16Zydus LifesciencesIndia13 November 2008
100 tablet, film coated in 1 bottle68382-114-01Zydus LifesciencesIndia13 November 2008
500 tablet, film coated in 1 bottle68382-114-05Zydus LifesciencesIndia13 November 2008
30 tablet, film coated in 1 bottle68382-114-06Zydus LifesciencesIndia13 November 2008
1000 tablet, film coated in 1 bottle68382-114-10Zydus LifesciencesIndia13 November 2008
60 tablet, film coated in 1 bottle68382-114-14Zydus LifesciencesIndia13 November 2008
90 tablet, film coated in 1 bottle68382-114-16Zydus LifesciencesIndia13 November 2008
60 tablet in 1 bottle27241-001-06Ajanta PharmaIndia28 March 2014
500 tablet in 1 bottle27241-001-50Ajanta PharmaIndia28 March 2014
500 tablet in 1 bottle59746-223-05Jubilant Cadista PharmacuticalsIndia15 October 2025
60 tablet in 1 bottle59746-223-60Jubilant Cadista PharmacuticalsIndia15 October 2025
100 tablet in 1 bottle13668-037-01Torrent PharmaceuticalsIndia1 January 2009
500 tablet in 1 bottle13668-037-05Torrent PharmaceuticalsIndia1 January 2009
4200 tablet in 1 bottle13668-037-55Torrent PharmaceuticalsIndia1 January 2009
60 tablet in 1 bottle13668-037-60Torrent PharmaceuticalsIndia1 January 2009
500 tablet in 1 bottle69238-2110-5Amneal Pharmaceuticals NY1 August 2021
60 tablet in 1 bottle69238-2110-6Amneal Pharmaceuticals NY1 August 2021
60 tablet, film coated in 1 bottle62135-602-60Chartwell RX29 December 2023
60 tablet in 1 bottle43547-341-06Solco Healthcare1 June 2014
500 tablet in 1 bottle43547-341-50Solco Healthcare1 June 2014
30 tablet in 1 bottle, plastic43063-254-30PD-Rx Pharmaceuticals3 June 2010
60 tablet in 1 bottle, plastic43063-254-60PD-Rx Pharmaceuticals3 June 2010
7 tablet in 1 bottle, plastic43063-908-07PD-Rx Pharmaceuticals11 August 2022
30 tablet in 1 bottle, plastic43063-908-30PD-Rx Pharmaceuticals27 November 2018
60 tablet in 1 bottle, plastic43063-908-60PD-Rx Pharmaceuticals27 November 2018
30 tablet in 1 blister pack70518-0364-0Remedyrepack27 March 2017
30 tablet in 1 bottle, plastic70518-0364-2Remedyrepack22 August 2025
50 pouch in 1 box / 1 tablet in 1 pouch70518-0364-3Remedyrepack21 May 2026
30 tablet in 1 blister pack70518-3883-0Remedyrepack28 September 2023
60 tablet in 1 blister pack70518-3883-1Remedyrepack28 September 2023
30 tablet in 1 blister pack70518-3883-2Remedyrepack22 January 2025
30 tablet in 1 bottle50090-3341-0A-S Medication Solutions22 January 2018
60 tablet in 1 bottle50090-3341-1A-S Medication Solutions6 November 2023
100 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack68084-272-01American Health Packaging2 December 2008
500 tablet, film coated in 1 bottle42291-976-50AvKARE6 March 2025

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 29 December 1993Drugs@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 Risperidone 1 mg tablet.

Compare 1

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 Risperidone

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

Data sources

Need Risperidone 1 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.