Medicine
Paxil CR 12.5 mg extended-release tablet
Paxil CR 12.5 mg extended-release tablet is a prescription medicine containing Paroxetine for oral use, marketed by Apotex, 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 or below 20° to 25°C (68° to 77°F), excursions permitted between 15°…
Key facts
- Active ingredient (INN)
- Paroxetine
- Brand
- Paxil CR
- Strength
- 12.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Apotex
- Manufacturer
- Apotex
- Origin register
- US FDA, United States
- Storage
- Store at or below 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 30°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
- 1 January 2011
- Identifiers
- RxCUI 1738803, 1738804, 1738805 +3DailyMed set ID 483bd97f-c4d0-4e23-aaa8-6334f4471e0cNDC 60505-4377Application NDA020936
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated, extended release in 1 bottle | 60505-4377-3 | Apotex | 1 January 2011 |
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 Paxil CR 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.