Medicine
Fluvoxamine 100 mg extended-release capsule
Fluvoxamine 100 mg extended-release capsule 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
Fluvoxamine maleate extended-release capsules should be protected from high…
Key facts
- Active ingredient (INN)
- Fluvoxamine
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 30 capsules, 100 capsules, 1000 capsules and 8 more
- Manufacturers
- Camber PharmaceuticalsIndiaZydus LifesciencesIndiaAjanta PharmaIndiaBionpharmaActavis PharmaAvKAREPar HealthUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Fluvoxamine maleate extended-release capsules should be protected from high humidity and stored at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Avoid exposure to temperatures above 30°C (86°F). Storage Keep out of reach of children.
- 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
- 13 March 2013
- Identifiers
- RxCUI 903873, 903879DailyMed set ID 0a6836ab-bd0e-410b-82af-07720e386532, 9924422b-7c90-42bf-a680-ffd92063d5f0, 8bbd7e39-b9ab-4716-9522-aa8c4b92210e +6NDC 27241-274, 69452-182, 0228-2848 +6Application ANDA219055, ANDA212182, ANDA091482 +4
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 capsule, extended release in 1 bottle | 70710-1847-3 | Zydus LifesciencesIndia | 4 August 2026 |
| 30 capsule, extended release in 1 bottle | 70771-1957-3 | Zydus LifesciencesIndia | 4 August 2026 |
| 30 capsule, extended release in 1 bottle | 27241-274-30 | Ajanta PharmaIndia | 17 October 2024 |
| 100 capsule, extended release in 1 bottle | 31722-064-01 | Camber PharmaceuticalsIndia | 30 July 2025 |
| 30 capsule, extended release in 1 bottle | 31722-064-30 | Camber PharmaceuticalsIndia | 30 July 2025 |
| 30 capsule, extended release in 1 bottle | 0228-2848-03 | Actavis Pharma | 5 August 2014 |
| 30 capsule, extended release in 1 bottle | 69452-182-13 | Bionpharma | 1 December 2020 |
| 1000 capsule, extended release in 1 bottle | 69452-182-32 | Bionpharma | 1 December 2020 |
| 30 capsule, extended release in 1 bottle | 10370-175-11 | Par Health | 13 March 2013 |
| 30 capsule, extended release in 1 bottle | 0832-6025-30 | Upsher-Smith Laboratories | 15 May 2026 |
| 30 capsule, extended release in 1 bottle | 73190-066-30 | AvKARE | 4 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.
| 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 100 mg extended-release capsule 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.