Medicine
Fluphenazine 5 mg/mL oral concentrate
Fluphenazine 5 mg/mL oral concentrate is a generic prescription medicine for oral use, 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
Avoid freezing. Store at 20° to 25° C (68° to 77° F). Protect from light.
Key facts
- Active ingredient (INN)
- Fluphenazine
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Oral concentrate
- Route
- Oral
- Packs
- 120 mL
- Manufacturer
- PAI Pharma
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. 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
- N05AB02 Fluphenazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 September 2010
- Identifiers
- RxCUI 861848DailyMed set ID 0860b3f3-3116-40f8-bcb0-e5c47731bdc8NDC 0121-0653Application ANDA074725
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 |
|---|---|---|---|
| 120 mL in 1 bottle, dropper | 0121-0653-04 | PAI Pharma | 1 September 2010 |
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 9 September 1959 | 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 Fluphenazine
Clinical summary
Fluphenazine is a phenothiazine indicated in the management of manifestations of psychotic disorders. It is available as tablets, elixir and injection for oral and intramuscular use. MedsAcross supplies Fluphenazine 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 FluphenazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- fluphenazine hydrochloride prescribing information (Amneal Pharmaceuticals NY) · U.S. National Library of Medicine, DailyMed
Need Fluphenazine 5 mg/mL oral concentrate 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.