Medicine
Paroxetine 12.5 mg extended-release tablet
Paroxetine 12.5 mg extended-release tablet is a generic prescription medicine for oral use, made by 8 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).
Key facts
- Active ingredient (INN)
- Paroxetine
- Brand
- Sold under the generic name
- Strength
- 12.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 1000 tablets, 500 tablets and 10 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCadila PharmaceuticalsIndiaLannettModavar PharmaceuticalsApotexChartwell RXWestminster Pharmaceuticals8 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AB05 Paroxetine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 October 2014
- Identifiers
- RxCUI 1738803, 1738805, 1738807DailyMed set ID f22886f5-230c-47e4-9dd8-ffb14c8d6ae4, d315e0da-f829-408b-be5d-2bca2e06913c, 5e43cdbd-2419-434b-96b9-920f02558d1c +6NDC 62175-470, 68180-647, 71209-094 +6Application ANDA204744, ANDA204134, ANDA212645 +3
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, film coated, extended release in 1 bottle | 46708-766-30 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 1000 tablet, film coated, extended release in 1 bottle | 46708-766-91 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 62332-766-30 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 1000 tablet, film coated, extended release in 1 bottle | 62332-766-91 | Alembic PharmaceuticalsIndia | 31 March 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 71209-094-01 | Cadila PharmaceuticalsIndia | 14 February 2020 |
| 500 tablet, film coated, extended release in 1 bottle | 71209-094-10 | Cadila PharmaceuticalsIndia | 14 February 2020 |
| 30 tablet, film coated, extended release in 1 bottle | 60505-1316-3 | Apotex | 9 August 2019 |
| 30 tablet, film coated, extended release in 1 bottle | 62135-425-30 | Chartwell RX | 5 December 2022 |
| 30 tablet, film coated, extended release in 1 bottle | 62175-470-32 | Lannett | 31 October 2014 |
| 500 tablet, film coated, extended release in 1 bottle | 62175-470-41 | Lannett | 31 October 2014 |
| 500 tablet, film coated, extended release in 1 bottle | 72241-029-10 | Modavar Pharmaceuticals | 20 October 2021 |
| 30 tablet, film coated, extended release in 1 bottle | 72241-029-22 | Modavar Pharmaceuticals | 20 October 2021 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 69367-335-30 | Westminster Pharmaceuticals | 26 July 2021 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 December 1992 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Paroxetine 12.5 mg extended-release tablet.
Other strengths and forms of Paroxetine
Clinical summary
Paroxetine is a serotonin reuptake inhibitor. It is available as tablets, extended-release tablets and capsules for oral use. MedsAcross supplies Paroxetine 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 ParoxetineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PAXIL prescribing information (Apotex) · U.S. National Library of Medicine, DailyMed
Need Paroxetine 12.5 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.