Medicine
Fluoxetine 10 mg tablet
Fluoxetine 10 mg tablet is a generic prescription medicine for oral use, made by 11 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). Protect from light.
Key facts
- Active ingredient (INN)
- Fluoxetine
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 1000 tablets and 41 more
- Manufacturers
- Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaTorrent PharmaceuticalsIndiaAurobindo PharmaIndiaStrides PharmaIndiaLupinIndiaBryant Ranch PrepackScieGen PharmaceuticalsPar Health11 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- 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
- 22 August 2016
- Identifiers
- RxCUI 313990, 248642, 2532159 +1DailyMed set ID 97e7929f-dec4-467d-93c2-93360884e9e9, ac1651cc-4a2e-47cf-8a7e-be7ddcaf9f31, 3daecd20-6a59-44d3-8269-4912214c08b4 +16NDC 71335-2784, 70518-4429, 59651-308 +16Application ANDA213286, ANDA208698, ANDA203836 +5
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 11 labelers. The register lists 44 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 46708-242-30 | Alembic PharmaceuticalsIndia | 15 April 2017 |
| 100 tablet, film coated in 1 bottle | 46708-242-31 | Alembic PharmaceuticalsIndia | 15 April 2017 |
| 1000 tablet, film coated in 1 bottle | 46708-242-91 | Alembic PharmaceuticalsIndia | 15 April 2017 |
| 30 tablet, film coated in 1 bottle | 62332-242-30 | Alembic PharmaceuticalsIndia | 7 April 2017 |
| 100 tablet, film coated in 1 bottle | 62332-242-31 | Alembic PharmaceuticalsIndia | 7 April 2017 |
| 1000 tablet, film coated in 1 bottle | 62332-242-91 | Alembic PharmaceuticalsIndia | 7 April 2017 |
| 100 tablet, film coated in 1 bottle | 59651-308-01 | Aurobindo PharmaIndia | 8 April 2020 |
| 30 tablet, film coated in 1 bottle | 59651-308-30 | Aurobindo PharmaIndia | 8 April 2020 |
| 100 tablet, film coated in 1 bottle | 84386-104-01 | Aurobindo PharmaIndia | 15 January 2026 |
| 30 tablet, film coated in 1 bottle | 84386-104-30 | Aurobindo PharmaIndia | 15 January 2026 |
| 100 tablet, film coated in 1 bottle | 55111-150-01 | Dr. Reddy's LaboratoriesIndia | 30 September 2016 |
| 500 tablet, film coated in 1 bottle | 55111-150-05 | Dr. Reddy's LaboratoriesIndia | 30 September 2016 |
| 1000 tablet, film coated in 1 bottle | 55111-150-10 | Dr. Reddy's LaboratoriesIndia | 30 September 2016 |
| 30 tablet, film coated in 1 bottle | 55111-150-30 | Dr. Reddy's LaboratoriesIndia | 30 September 2016 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 55111-150-78 | Dr. Reddy's LaboratoriesIndia | 30 September 2016 |
| 100 tablet in 1 bottle | 68180-998-01 | LupinIndia | 7 August 2019 |
| 30 tablet in 1 bottle | 68180-998-06 | LupinIndia | 7 August 2019 |
| 30 tablet in 1 bottle | 64380-902-04 | Strides PharmaIndia | 12 August 2024 |
| 100 tablet in 1 bottle | 64380-902-06 | Strides PharmaIndia | 12 August 2024 |
| 1000 tablet in 1 bottle | 64380-902-08 | Strides PharmaIndia | 12 August 2024 |
| 100 tablet in 1 bottle | 13668-443-01 | Torrent PharmaceuticalsIndia | 21 October 2016 |
| 1000 tablet in 1 bottle | 13668-443-10 | Torrent PharmaceuticalsIndia | 21 October 2016 |
| 30 tablet in 1 bottle | 13668-443-30 | Torrent PharmaceuticalsIndia | 21 October 2016 |
| 100 tablet in 1 carton | 13668-443-74 | Torrent PharmaceuticalsIndia | 21 October 2016 |
| 28 tablet in 1 carton | 13668-443-91 | Torrent PharmaceuticalsIndia | 21 October 2016 |
| 100 tablet, coated in 1 bottle, plastic | 49884-335-01 | Par Health | 22 August 2016 |
| 30 tablet, coated in 1 bottle, plastic | 49884-335-11 | Par Health | 22 August 2016 |
| 100 tablet, film coated in 1 bottle | 50228-420-01 | ScieGen Pharmaceuticals | 20 March 2019 |
| 1000 tablet, film coated in 1 bottle | 50228-420-10 | ScieGen Pharmaceuticals | 20 March 2019 |
| 30 tablet, film coated in 1 bottle | 50228-420-30 | ScieGen Pharmaceuticals | 20 March 2019 |
| 30 tablet, coated in 1 bottle, plastic | 63629-2197-1 | Bryant Ranch Prepack | 22 August 2016 |
| 100 tablet, coated in 1 bottle, plastic | 63629-2198-1 | Bryant Ranch Prepack | 22 August 2016 |
| 30 tablet, film coated in 1 bottle | 63629-5930-1 | Bryant Ranch Prepack | 2 June 2025 |
| 60 tablet, coated in 1 bottle, plastic | 63629-8989-1 | Bryant Ranch Prepack | 7 December 2021 |
| 90 tablet, coated in 1 bottle, plastic | 63629-8989-2 | Bryant Ranch Prepack | 7 December 2021 |
| 30 tablet, film coated in 1 bottle | 71335-2778-1 | Bryant Ranch Prepack | 13 October 2025 |
| 100 tablet, film coated in 1 bottle | 71335-2778-2 | Bryant Ranch Prepack | 13 October 2025 |
| 30 tablet, film coated in 1 bottle | 71335-2784-1 | Bryant Ranch Prepack | 18 August 2025 |
| 100 tablet, film coated in 1 bottle | 71335-2784-2 | Bryant Ranch Prepack | 18 August 2025 |
| 100 tablet, coated in 1 bottle, plastic | 72162-1494-1 | Bryant Ranch Prepack | 4 October 2023 |
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
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 10 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.