Medicine
Fluoxetine 40 mg capsule
Fluoxetine 40 mg capsule is a generic prescription medicine for oral use, made by 27 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° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Fluoxetine
- Brand
- Sold under the generic name
- Strength
- 40 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 100 capsules, 500 capsules and 134 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaAvet PharmaceuticalsIndiaCadila PharmaceuticalsIndiaTime Cap LaboratoriesIndiaMarksans PharmaIndiaScieGen PharmaceuticalsModavar PharmaceuticalsTeva PharmaceuticalsRadha Pharmaceuticals27 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store 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
- N06AB03 Fluoxetine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 January 2002
- Identifiers
- RxCUI 313989, 310384, 310385DailyMed set ID 992060ee-fb4e-4c6d-9ffe-30902bc63af2, be4c5102-e0aa-3b89-e053-2a95a90a5d9d, ef699ed0-fd9e-4580-93bb-6fd50499dbd1 +37NDC 71335-1145, 68071-2375, 71205-393 +37Application ANDA078619, ANDA204597, ANDA201336 +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
A sample of 40 packs from 27 labelers. The register lists 137 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule in 1 bottle | 46708-273-30 | Alembic PharmaceuticalsIndia | 1 July 2009 |
| 100 capsule in 1 bottle | 46708-273-31 | Alembic PharmaceuticalsIndia | 1 July 2009 |
| 500 capsule in 1 bottle | 46708-273-71 | Alembic PharmaceuticalsIndia | 1 July 2009 |
| 1000 capsule in 1 bottle | 46708-273-91 | Alembic PharmaceuticalsIndia | 1 July 2009 |
| 30 capsule in 1 bottle | 62332-024-30 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 100 capsule in 1 bottle | 62332-024-31 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 500 capsule in 1 bottle | 62332-024-71 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 1000 capsule in 1 bottle | 62332-024-91 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 100 capsule in 1 bottle | 59651-900-00 | Aurobindo PharmaIndia | 11 July 2025 |
| 500 capsule in 1 bottle | 59651-900-05 | Aurobindo PharmaIndia | 11 July 2025 |
| 30 capsule in 1 bottle | 59651-900-30 | Aurobindo PharmaIndia | 11 July 2025 |
| 1000 capsule in 1 bottle | 59651-900-99 | Aurobindo PharmaIndia | 11 July 2025 |
| 100 capsule in 1 bottle | 65862-194-01 | Aurobindo PharmaIndia | 31 January 2008 |
| 500 capsule in 1 bottle | 65862-194-05 | Aurobindo PharmaIndia | 31 January 2008 |
| 30 capsule in 1 bottle | 65862-194-30 | Aurobindo PharmaIndia | 31 January 2008 |
| 1000 capsule in 1 bottle | 65862-194-99 | Aurobindo PharmaIndia | 31 January 2008 |
| 100 capsule in 1 bottle | 23155-030-01 | Avet PharmaceuticalsIndia | 13 October 2024 |
| 30 capsule in 1 bottle | 23155-030-03 | Avet PharmaceuticalsIndia | 13 October 2024 |
| 500 capsule in 1 bottle | 23155-030-05 | Avet PharmaceuticalsIndia | 13 October 2024 |
| 1000 capsule in 1 bottle | 23155-030-10 | Avet PharmaceuticalsIndia | 13 October 2024 |
| 30 capsule in 1 bottle | 71209-042-01 | Cadila PharmaceuticalsIndia | 15 December 2022 |
| 100 capsule in 1 bottle | 71209-042-05 | Cadila PharmaceuticalsIndia | 15 December 2022 |
| 500 capsule in 1 bottle | 71209-042-10 | Cadila PharmaceuticalsIndia | 15 December 2022 |
| 100 capsule in 1 bottle | 25000-149-08 | Marksans PharmaIndia | 16 June 2022 |
| 500 capsule in 1 bottle | 25000-149-12 | Marksans PharmaIndia | 29 January 2022 |
| 100 capsule in 1 bottle | 49483-703-01 | Time Cap LaboratoriesIndia | 12 February 2022 |
| 30 capsule in 1 bottle | 49483-703-03 | Time Cap LaboratoriesIndia | 12 February 2022 |
| 500 capsule in 1 bottle | 49483-703-50 | Time Cap LaboratoriesIndia | 12 February 2022 |
| 100 capsule in 1 bottle | 72241-009-05 | Modavar Pharmaceuticals | 8 September 2021 |
| 500 capsule in 1 bottle | 72241-009-10 | Modavar Pharmaceuticals | 8 September 2021 |
| 30 capsule in 1 bottle | 72241-009-22 | Modavar Pharmaceuticals | 8 September 2021 |
| 100 capsule in 1 bottle | 77771-115-01 | Radha Pharmaceuticals | 24 October 2022 |
| 500 capsule in 1 bottle | 77771-115-05 | Radha Pharmaceuticals | 24 October 2022 |
| 100 capsule in 1 bottle | 50228-115-01 | ScieGen Pharmaceuticals | 16 March 2015 |
| 500 capsule in 1 bottle | 50228-115-05 | ScieGen Pharmaceuticals | 16 March 2015 |
| 1000 capsule in 1 bottle | 50228-115-10 | ScieGen Pharmaceuticals | 20 August 2026 |
| 30 capsule in 1 bottle | 50228-115-30 | ScieGen Pharmaceuticals | 16 March 2015 |
| 100 capsule in 1 bottle | 0093-7198-01 | Teva Pharmaceuticals | 8 September 2008 |
| 500 capsule in 1 bottle | 0093-7198-05 | Teva Pharmaceuticals | 23 September 2008 |
| 30 capsule in 1 bottle | 0093-7198-56 | Teva Pharmaceuticals | 30 January 2002 |
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 1987 | 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 Fluoxetine 40 mg capsule.
Other strengths and forms of Fluoxetine
Clinical summary
Fluoxetine is a serotonin reuptake inhibitor indicated for the treatment of acute and maintenance treatment of Major Depressive Disorder, among other approved uses. It is available as capsules, tablets and oral solution. MedsAcross supplies Fluoxetine 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 FluoxetineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prozac prescribing information (Dista Products) · U.S. National Library of Medicine, DailyMed
Need Fluoxetine 40 mg 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.