Medicine
Paliperidone 1.5 mg extended-release tablet
Paliperidone 1.5 mg extended-release tablet is a generic prescription medicine for oral use, made by 12 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 at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Paliperidone
- Brand
- Sold under the generic name
- Strength
- 1.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 90 tablets and 14 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAjanta PharmaIndiaCamber PharmaceuticalsIndiaEskayef PharmaceuticalsAmneal PharmaceuticalsANI PharmaceuticalsAvKAREBryant Ranch PrepackNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F 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 672567, 672569, 672571 +1DailyMed set ID 71985eb4-07df-41c9-8b9a-85f39e92b7d0, bbbaa057-f587-4eb9-a0d2-463dbcd57661, be30f3cc-55fb-4a74-9778-60573a7f18c6 +9NDC 27241-276, 43975-349, 46708-803 +10Application ANDA218514, ANDA204452, ANDA218330 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, extended release in 1 bottle | 46708-803-30 | Alembic PharmaceuticalsIndia | 30 September 2024 |
| 30 tablet, extended release in 1 bottle | 62332-803-30 | Alembic PharmaceuticalsIndia | 30 September 2024 |
| 30 tablet, extended release in 1 bottle | 27241-276-30 | Ajanta PharmaIndia | 26 June 2024 |
| 30 tablet, extended release in 1 bottle | 31722-317-30 | Camber PharmaceuticalsIndia | 23 August 2023 |
| 30 tablet, film coated, extended release in 1 bottle | 47335-744-83 | Sun Pharmaceutical IndustriesIndia | 1 August 2018 |
| 100 tablet, film coated, extended release in 1 bottle | 47335-744-88 | Sun Pharmaceutical IndustriesIndia | 1 August 2018 |
| 30 tablet, extended release in 1 bottle | 65162-280-03 | Amneal Pharmaceuticals | 24 September 2019 |
| 90 tablet, extended release in 1 bottle | 65162-280-09 | Amneal Pharmaceuticals | 24 September 2019 |
| 30 tablet, extended release in 1 bottle | 43975-349-03 | ANI Pharmaceuticals | 27 November 2019 |
| 30 tablet, extended release in 1 bottle | 72658-1253-1 | Eskayef Pharmaceuticals | 2 October 2025 |
| 100 tablet, extended release in 1 bottle | 72658-1253-2 | Eskayef Pharmaceuticals | 2 October 2025 |
| 500 tablet, extended release in 1 bottle | 72658-1253-3 | Eskayef Pharmaceuticals | 2 October 2025 |
| 30 tablet, extended release in 1 bottle | 27808-222-01 | Tris Pharma | 25 October 2021 |
| 30 tablet, extended release in 1 bottle | 42291-915-30 | AvKARE | 28 July 2023 |
| 30 tablet, extended release in 1 bottle | 72162-2648-3 | Bryant Ranch Prepack | 27 May 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 16714-866-01 | NorthStar RxLLC | 15 October 2018 |
| 30 tablet, extended release in 1 bottle | 69367-432-30 | Westminster Pharmaceuticals | 9 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.
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 1.5 mg extended-release tablet.
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 PaliperidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- INVEGA prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Byannli (previously Paliperidone Janssen-Cilag International): European public assessment report (EPAR) · European Medicines Agency
- Invega: European public assessment report (EPAR) · European Medicines Agency
Need Paliperidone 1.5 mg extended-release tablet for your hospital or patient?
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