Medicine
Fluoxetine 20 mg/5 mL oral solution
Fluoxetine 20 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 5 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 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Fluoxetine
- Brand
- Sold under the generic name
- Strength
- 20 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 120 mL, 4 trays and 3 more
- Manufacturers
- Aurobindo PharmaIndiaPAI PharmaAmerican Health PackagingANI PharmaceuticalsSaptalis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°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
- 30 January 2002
- Identifiers
- RxCUI 310386DailyMed set ID 1ffe57c3-6f70-4075-aacb-d87a3990fdea, 180a07fd-1f6a-4617-b8e0-f938c65ba273, 3195db14-0cae-4b49-9fba-49b869fe92a8 +2NDC 70954-600, 0121-4721, 0121-0721 +3Application ANDA216448, ANDA076015, ANDA079209 +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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 mL in 1 bottle, glass | 65862-306-12 | Aurobindo PharmaIndia | 19 March 2009 |
| 120 mL in 1 bottle | 0121-0721-04 | PAI Pharma | 30 January 2002 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-4721-40 | PAI Pharma | 1 February 2002 |
| 120 mL in 1 bottle, plastic | 70954-600-10 | ANI Pharmaceuticals | 9 November 2022 |
| 120 mL in 1 bottle | 71656-089-04 | Saptalis Pharmaceuticals | 20 June 2025 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-845-77 | American Health Packaging | 4 December 2024 |
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 20 mg/5 mL oral solution 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.