Medicine
Fluoxetine 60 mg tablet
Fluoxetine 60 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
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
- 60 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 14 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaLupinIndiaStrides PharmaIndiaScieGen PharmaceuticalsBryant Ranch PrepackNorthStar RxPar Health
- 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
- 16 November 2017
- Identifiers
- RxCUI 1190110DailyMed set ID 5336ce59-7a6c-4db9-8512-299cc5e599c0, a7ba9184-7dad-4f82-a947-bb2cc6b760ce, f274f102-67ec-46e7-b248-533be2e3003b +10NDC 59651-324, 50228-422, 68180-997 +10Application ANDA213265, ANDA211282, ANDA211632 +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 tablet, film coated in 1 bottle | 59651-324-30 | Aurobindo PharmaIndia | 10 June 2020 |
| 30 tablet, film coated in 1 bottle | 84386-106-30 | Aurobindo PharmaIndia | 15 January 2026 |
| 100 tablet, film coated in 1 bottle | 43598-632-01 | Dr. Reddy's LaboratoriesIndia | 28 January 2019 |
| 30 tablet, film coated in 1 bottle | 43598-632-30 | Dr. Reddy's LaboratoriesIndia | 28 January 2019 |
| 30 tablet in 1 bottle | 68180-997-06 | LupinIndia | 9 April 2019 |
| 30 tablet in 1 bottle | 64380-900-04 | Strides PharmaIndia | 8 November 2024 |
| 500 tablet, film coated in 1 bottle | 51672-5306-2 | Sun Pharmaceutical IndustriesIndia | 15 February 2019 |
| 30 tablet, film coated in 1 bottle | 51672-5306-6 | Sun Pharmaceutical IndustriesIndia | 15 February 2019 |
| 1000 tablet in 1 bottle | 50228-422-10 | ScieGen Pharmaceuticals | 10 January 2019 |
| 30 tablet in 1 bottle | 50228-422-30 | ScieGen Pharmaceuticals | 10 January 2019 |
| 1000 tablet in 1 bottle | 50228-638-10 | ScieGen Pharmaceuticals | 11 September 2025 |
| 30 tablet in 1 bottle | 50228-638-30 | ScieGen Pharmaceuticals | 11 September 2025 |
| 30 tablet, film coated in 1 bottle | 49884-468-11 | Par Health | 16 November 2017 |
| 30 tablet, film coated in 1 bottle | 63629-2201-1 | Bryant Ranch Prepack | 28 October 2022 |
| 30 tablet, film coated in 1 bottle | 71335-2597-1 | Bryant Ranch Prepack | 12 February 2025 |
| 30 tablet, film coated in 1 bottle | 72162-1506-3 | Bryant Ranch Prepack | 8 April 2024 |
| 30 tablet, film coated in 1 bottle | 16714-114-01 | NorthStar Rx | 18 September 2019 |
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 60 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.