Medicine
Fluphenazine 1 mg tablet
Fluphenazine 1 mg tablet is a generic prescription medicine for oral use, made by 21 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)
- Fluphenazine
- Brand
- Sold under the generic name
- Strength
- 1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 100 blister pack and 38 more
- Manufacturers
- Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaGlenmark PharmaceuticalsIndiaCamber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAjanta PharmaIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaProficient Rx
- 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
- N05AB02 Fluphenazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 August 1988
- Identifiers
- RxCUI 865117, 859841, 860918 +1DailyMed set ID 53864ae1-046e-f6de-e063-6294a90a13af, 37c9712b-95a1-fcc4-e063-6394a90aca50, 977dc369-6b6d-4ad1-9239-a46f63a764bd +21NDC 67046-0975, 67046-1567, 70771-1581 +22Application ANDA213647, ANDA218173, ANDA214552 +12
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 21 labelers. The register lists 41 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 46708-788-31 | Alembic PharmaceuticalsIndia | 25 July 2024 |
| 500 tablet, film coated in 1 bottle | 46708-788-71 | Alembic PharmaceuticalsIndia | 25 July 2024 |
| 100 tablet, film coated in 1 bottle | 62332-788-31 | Alembic PharmaceuticalsIndia | 25 July 2024 |
| 500 tablet, film coated in 1 bottle | 62332-788-71 | Alembic PharmaceuticalsIndia | 25 July 2024 |
| 100 tablet, film coated in 1 bottle | 70710-1488-1 | Zydus LifesciencesIndia | 28 May 2021 |
| 500 tablet, film coated in 1 bottle | 70710-1488-5 | Zydus LifesciencesIndia | 28 May 2021 |
| 100 tablet, film coated in 1 bottle | 70771-1581-1 | Zydus LifesciencesIndia | 28 May 2021 |
| 500 tablet, film coated in 1 bottle | 70771-1581-5 | Zydus LifesciencesIndia | 28 May 2021 |
| 100 tablet in 1 bottle | 27241-255-01 | Ajanta PharmaIndia | 5 January 2023 |
| 100 tablet in 1 bottle | 59651-686-01 | Aurobindo PharmaIndia | 18 August 2023 |
| 100 tablet, film coated in 1 bottle | 31722-384-01 | Camber PharmaceuticalsIndia | 18 November 2025 |
| 500 tablet, film coated in 1 bottle | 31722-384-05 | Camber PharmaceuticalsIndia | 18 November 2025 |
| 100 tablet, film coated in 1 bottle, plastic | 43598-034-01 | Dr. Reddy's LaboratoriesIndia | 15 February 2021 |
| 100 tablet, film coated in 1 bottle, plastic | 68462-914-01 | Glenmark PharmaceuticalsIndia | 30 December 2024 |
| 500 tablet, film coated in 1 bottle, plastic | 68462-914-05 | Glenmark PharmaceuticalsIndia | 30 December 2024 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 68462-914-14 | Glenmark PharmaceuticalsIndia | 30 December 2024 |
| 500 tablet, film coated in 1 bottle, plastic | 72205-112-05 | Novadoz PharmaceuticalsIndia | 14 September 2023 |
| 100 tablet, film coated in 1 bottle, plastic | 72205-112-91 | Novadoz PharmaceuticalsIndia | 14 September 2023 |
| 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle | 51672-4233-1 | Sun Pharmaceutical IndustriesIndia | 14 April 2022 |
| 100 tablet, film coated in 1 bottle, plastic | 24979-136-01 | Upsher-Smith Laboratories | 1 August 2022 |
| 100 tablet, film coated in 1 bottle, plastic | 69238-1678-1 | Amneal Pharmaceuticals NY | 11 July 2020 |
| 100 tablet in 1 bottle | 70954-273-10 | ANI Pharmaceuticals | 1 March 2021 |
| 90 tablet, film coated in 1 bottle | 62135-415-90 | Chartwell RX | 20 October 2022 |
| 100 tablet, film coated in 1 bottle, plastic | 0527-1788-01 | Lannett | 25 August 1988 |
| 500 tablet, film coated in 1 bottle, plastic | 0527-1788-05 | Lannett | 25 August 1988 |
| 100 tablet, film coated in 1 bottle | 90096-121-01 | Zameer Pharmaceuticals | 1 January 2022 |
| 30 tablet, film coated in 1 blister pack | 67046-0975-3 | Coupler | 5 June 2026 |
| 30 tablet, film coated in 1 blister pack | 67046-1567-3 | Coupler | 17 June 2025 |
| 50 blister pack in 1 box / 1 tablet, film coated in 1 blister pack | 50268-366-15 | AvPAK | 6 July 2022 |
| 100 tablet, film coated in 1 bottle, plastic | 51407-458-01 | Golden State Medical Supply | 3 March 2021 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0904-7157-61 | Major Pharmaceuticals | 25 August 1988 |
| 100 tablet in 1 bottle | 10135-725-01 | Marlex Pharmaceuticals | 1 June 2021 |
| 100 tablet, film coated in 1 bottle, plastic | 71205-837-00 | Proficient Rx | 21 February 2023 |
| 1000 tablet, film coated in 1 bottle, plastic | 71205-837-11 | Proficient Rx | 21 February 2023 |
| 30 tablet, film coated in 1 bottle, plastic | 71205-837-30 | Proficient Rx | 21 February 2023 |
| 500 tablet, film coated in 1 bottle, plastic | 71205-837-55 | Proficient Rx | 21 February 2023 |
| 60 tablet, film coated in 1 bottle, plastic | 71205-837-60 | Proficient Rx | 21 February 2023 |
| 240 tablet, film coated in 1 bottle, plastic | 71205-837-64 | Proficient Rx | 21 February 2023 |
| 120 tablet, film coated in 1 bottle, plastic | 71205-837-72 | Proficient Rx | 21 February 2023 |
| 180 tablet, film coated in 1 bottle, plastic | 71205-837-78 | Proficient Rx | 21 February 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 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
Alternatives
Other makers and brands of Fluphenazine 1 mg tablet.
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 1 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.