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Medicine

Paliperidone 6 mg extended-release tablet

Paliperidone · Oral
Available on requestPrescription onlyUS FDAGeneric name

Paliperidone 6 mg extended-release tablet is a generic prescription medicine for oral use, made by 17 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

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…

Key facts

Active ingredient (INN)
Paliperidone
Brand
Sold under the generic name
Strength
6 mg
Dosage form
Extended-release tablet
Route
Oral
Packs
30 tablets, 100 tablets, 90 tablets and 19 more
Manufacturers
Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAjanta PharmaIndiaCamber PharmaceuticalsIndiaEskayef PharmaceuticalsAmneal PharmaceuticalsAmerican Health PackagingANI PharmaceuticalsArchis PharmaAvKARE
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N05AX13 Paliperidone
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 August 2018
Identifiers
RxCUI 672569, 672567, 672571 +1DailyMed set ID f75e884e-1883-45d7-ac9b-4a6c63f2185e, d7033e52-3df2-48e2-adda-15a57c2f148f, 528a962a-4924-4c48-93ce-6ab1f019e52c +14NDC 72162-2650, 27808-224, 0904-6936 +15Application ANDA218755, ANDA212807, ANDA205618 +6

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.

PackCodeLabelerMarketed since
30 tablet, extended release in 1 bottle46708-805-30Alembic PharmaceuticalsIndia30 September 2024
30 tablet, extended release in 1 bottle62332-805-30Alembic PharmaceuticalsIndia30 September 2024
30 tablet, extended release in 1 bottle27241-278-30Ajanta PharmaIndia26 June 2024
30 tablet, extended release in 1 bottle31722-319-30Camber PharmaceuticalsIndia23 August 2023
30 tablet, film coated, extended release in 1 bottle47335-766-83Sun Pharmaceutical IndustriesIndia1 August 2018
100 tablet, film coated, extended release in 1 bottle47335-766-88Sun Pharmaceutical IndustriesIndia1 August 2018
30 tablet, extended release in 1 bottle65162-282-03Amneal Pharmaceuticals24 September 2019
90 tablet, extended release in 1 bottle65162-282-09Amneal Pharmaceuticals24 September 2019
30 tablet, extended release in 1 bottle43975-351-03ANI Pharmaceuticals27 November 2019
30 tablet, film coated, extended release in 1 bottle, plastic72819-159-03Archis Pharma27 April 2022
30 tablet, extended release in 1 bottle72658-1255-1Eskayef Pharmaceuticals2 October 2025
100 tablet, extended release in 1 bottle72658-1255-2Eskayef Pharmaceuticals2 October 2025
500 tablet, extended release in 1 bottle72658-1255-3Eskayef Pharmaceuticals2 October 2025
30 tablet, extended release in 1 bottle27808-224-01Tris Pharma25 October 2021
100 blister pack in 1 box, unit-dose / 1 tablet, extended release in 1 blister pack60687-470-01American Health Packaging15 January 2020
30 tablet, extended release in 1 bottle42291-917-30AvKARE28 July 2023
30 tablet, extended release in 1 bottle72162-2650-3Bryant Ranch Prepack27 May 2026
30 tablet, extended release in 1 blister pack67046-1630-3Coupler18 December 2025
100 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack0904-6936-61Major Pharmaceuticals1 August 2018
30 tablet, film coated, extended release in 1 bottle16714-868-01NorthStar RxLLC15 October 2018
30 tablet, extended release in 1 blister pack70518-4268-0Remedyrepack27 January 2025
30 tablet, extended release in 1 bottle69367-434-30Westminster Pharmaceuticals9 December 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 19 December 2006Drugs@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 Paliperidone 6 mg extended-release tablet.

Compare 1

Other strengths and forms of Paliperidone

Clinical summary

Paliperidone is an atypical antipsychotic indicated for Treatment of schizophrenia, among other approved uses. It is available as extended-release tablets for oral use. MedsAcross supplies Paliperidone 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 Paliperidone

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

Need Paliperidone 6 mg extended-release 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.