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Medicine

Fluvoxamine 100 mg tablet

Fluvoxamine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Fluvoxamine 100 mg tablet is a generic prescription medicine for oral use, made by 9 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

NDC 71335-3006-1: 90 Tablets in a BOTTLE NDC 71335-3006-2: 30 Tablets in a…

Key facts

Active ingredient (INN)
Fluvoxamine
Brand
Sold under the generic name
Strength
100 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 1000 tablets and 27 more
Manufacturers
Bryant Ranch PrepackPreferred PharmaceuticalsBionpharmaA-S Medication SolutionsANI PharmaceuticalsApotexChartwell RXPD-Rx PharmaceuticalsRemedyrepack
Origin register
US FDA, United States
Storage
NDC 71335-3006-1: 90 Tablets in a BOTTLE NDC 71335-3006-2: 30 Tablets in a BOTTLE NDC 71335-3006-3: 18 Tablets in a BOTTLE NDC 71335-3006-4: 28 Tablets in a BOTTLE NDC 71335-3006-5: 100 Tablets in a BOTTLE Fluvoxamine maleate tablets, USP 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 c3d59ca9-dd42-4b1c-bd2d-23eb507598b8, b8320308-084f-43fb-9b1d-5620a0efaf46, a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3 +11NDC 71335-3006, 62135-933, 68788-8175 +11Application ANDA217917, ANDA075900, 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.

PackCodeLabelerMarketed since
100 tablet, film coated in 1 bottle69452-289-20Bionpharma23 May 2024
100 tablet in 1 bottle69452-455-20Bionpharma7 February 2025
500 tablet in 1 bottle69452-455-30Bionpharma7 February 2025
1000 tablet in 1 bottle69452-455-32Bionpharma7 February 2025
100 tablet, coated in 1 bottle62559-160-01ANI Pharmaceuticals9 August 2011
100 tablet in 1 bottle60505-0166-1Apotex10 July 2001
30 tablet, film coated in 1 bottle62135-933-30Chartwell RX18 December 2024
30 tablet in 1 bottle68788-4011-3Preferred Pharmaceuticals4 September 2025
60 tablet in 1 bottle68788-4011-6Preferred Pharmaceuticals4 September 2025
90 tablet in 1 bottle68788-4011-9Preferred Pharmaceuticals4 September 2025
30 tablet, coated in 1 bottle68788-7219-3Preferred Pharmaceuticals27 July 2018
60 tablet, coated in 1 bottle68788-7219-6Preferred Pharmaceuticals27 July 2018
90 tablet, coated in 1 bottle68788-7219-9Preferred Pharmaceuticals27 July 2018
30 tablet in 1 bottle68788-8175-3Preferred Pharmaceuticals27 April 2022
60 tablet in 1 bottle68788-8175-6Preferred Pharmaceuticals27 April 2022
90 tablet in 1 bottle68788-8175-9Preferred Pharmaceuticals27 April 2022
90 tablet, coated in 1 bottle50090-5988-0A-S Medication Solutions7 June 2022
90 tablet in 1 bottle50090-7728-0A-S Medication Solutions17 October 2025
90 tablet in 1 bottle71335-2008-1Bryant Ranch Prepack17 January 2022
30 tablet in 1 bottle71335-2008-2Bryant Ranch Prepack17 February 2022
18 tablet in 1 bottle71335-2008-3Bryant Ranch Prepack3 April 2024
28 tablet in 1 bottle71335-2008-4Bryant Ranch Prepack3 April 2024
100 tablet in 1 bottle71335-2008-5Bryant Ranch Prepack13 September 2023
90 tablet in 1 bottle71335-3006-1Bryant Ranch Prepack4 February 2026
30 tablet in 1 bottle71335-3006-2Bryant Ranch Prepack4 February 2026
18 tablet in 1 bottle71335-3006-3Bryant Ranch Prepack4 February 2026
28 tablet in 1 bottle71335-3006-4Bryant Ranch Prepack4 February 2026
100 tablet in 1 bottle71335-3006-5Bryant Ranch Prepack4 February 2026
30 tablet in 1 bottle, plastic72789-221-30PD-Rx Pharmaceuticals18 January 2022
30 tablet, coated in 1 blister pack70518-1057-0Remedyrepack13 March 2018

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 5 December 1994Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Fluvoxamine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Fluvoxamine 100 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.