Medicine
Prozac 10 mg capsule
Prozac 10 mg capsule is a prescription medicine containing Fluoxetine for oral use, marketed by Dista Products, 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 Controlled Room Temperature, 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Fluoxetine
- Brand
- Prozac
- Strength
- 10 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules
- Marketing authorisation holder
- Dista Products
- Manufacturer
- Dista Products
- Origin register
- US FDA, United States
- Storage
- Store at Controlled Room Temperature, 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
- 13 January 1993
- Identifiers
- RxCUI 104849, 205535, 261287 +3DailyMed set ID c88f33ed-6dfb-4c5e-bc01-d8e36dd97299NDC 0777-3104Application NDA018936
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 0777-3104-02 | Dista Products | 13 January 1993 |
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 10 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 Prozac 10 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.