Medicine
Fluvoxamine 50 mg tablet
Fluvoxamine 50 mg tablet is a generic prescription medicine for oral use, made by 7 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
Fluvoxamine maleate tablets should be protected from high humidity and stored…
Key facts
- Active ingredient (INN)
- Fluvoxamine
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 8 more
- Manufacturers
- BionpharmaBryant Ranch PrepackRemedyrepackAmerican Health PackagingANI PharmaceuticalsApotexChartwell RX
- Origin register
- US FDA, United States
- Storage
- Fluvoxamine maleate tablets should be protected from high humidity and stored at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AB08 Fluvoxamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 July 2001
- Identifiers
- RxCUI 903884, 903887, 903891DailyMed set ID b8320308-084f-43fb-9b1d-5620a0efaf46, 191912e6-b3c8-be1a-e063-6394a90a8dd4, 6eeb14df-6fcf-a737-5359-5744eb4accea +4NDC 62135-932, 69452-288, 60505-0165 +4Application ANDA075900, ANDA217917, ANDA075902 +1
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 |
|---|---|---|---|
| 100 tablet, coated in 1 bottle | 62559-159-01 | ANI Pharmaceuticals | 9 August 2011 |
| 100 tablet in 1 bottle | 60505-0165-1 | Apotex | 10 July 2001 |
| 100 tablet in 1 bottle | 69452-288-20 | Bionpharma | 23 May 2024 |
| 500 tablet in 1 bottle | 69452-288-30 | Bionpharma | 7 February 2025 |
| 1000 tablet in 1 bottle | 69452-288-32 | Bionpharma | 7 February 2025 |
| 60 tablet, film coated in 1 bottle | 62135-932-60 | Chartwell RX | 18 December 2024 |
| 30 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 68084-837-21 | American Health Packaging | 29 September 2014 |
| 60 tablet in 1 bottle | 71335-1974-1 | Bryant Ranch Prepack | 14 February 2022 |
| 30 tablet in 1 bottle | 71335-1974-2 | Bryant Ranch Prepack | 14 October 2021 |
| 30 tablet, coated in 1 blister pack | 70518-1643-0 | Remedyrepack | 7 October 2018 |
| 50 pouch in 1 box / 1 tablet, coated in 1 pouch | 70518-1643-1 | Remedyrepack | 23 April 2026 |
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 5 December 1994 | 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
Other strengths and forms of Fluvoxamine
Clinical summary
Fluvoxamine is a serotonin reuptake inhibitor indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD). It is available as tablets and extended-release capsules for oral use. MedsAcross supplies Fluvoxamine 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 FluvoxamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- fluvoxamine maleate prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fluvoxamine 50 mg 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.