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Medicine

Risperdal 1 mg tablet

Risperidone · Oral · Janssen Pharmaceuticals
Available on requestPrescription onlyUS FDA

Risperdal 1 mg tablet is a prescription medicine containing Risperidone for oral use, marketed by Janssen Pharmaceuticals, 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

Protect from light and freezing. RISPERDAL Tablets should be stored at…

Key facts

Active ingredient (INN)
Risperidone
Brand
Risperdal
Strength
1 mg
Dosage form
Tablet
Route
Oral
Packs
10 blister pack, 60 tablets
Marketing authorisation holder
Janssen Pharmaceuticals
Manufacturer
Janssen Pharmaceuticals
Origin register
US FDA, United States
Storage
Protect from light and freezing. RISPERDAL Tablets should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 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
29 December 1993
Identifiers
RxCUI 104781, 104782, 104783 +7DailyMed set ID 7e117c7e-02fc-4343-92a1-230061dfc5e0NDC 50458-300Application NDA020272

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

PackCodeLabelerMarketed since
10 blister pack in 1 box, unit-dose / 10 tablet in 1 blister pack50458-300-01Janssen Pharmaceuticals29 December 1993
60 tablet in 1 bottle50458-300-06Janssen Pharmaceuticals29 December 1993

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

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