Medicine
Fluphenazine decanoate 125 mg/5 mL injection
Fluphenazine decanoate 125 mg/5 mL injection is a generic prescription medicine for intramuscular, subcutaneous 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 (keep in outer carton).
Key facts
- Active ingredient (INN)
- Fluphenazine decanoate
- Brand
- Sold under the generic name
- Strength
- 125 mg/5 mL
- Dosage form
- Injection
- Route
- Intramuscular, subcutaneous
- Packs
- 1 vial of 5 mL and 7 more
- Manufacturers
- EugiaIndiaGland PharmaIndiaNovadoz PharmaceuticalsIndiaPar HealthBryant Ranch PrepackFresenius KabiHikma PharmaceuticalsMylan InstitutionalSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light (keep in outer carton).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 August 1996
- Identifiers
- RxCUI 859824DailyMed set ID 8d7ba627-cf3f-4b94-aee8-8b44cc9400be, 1f532edc-1a2c-4221-80dd-1ac158dd3a72, f8ba014e-aea0-49bc-8345-4e0a384b484e +7NDC 72205-100, 55150-267, 63323-272 +6Application ANDA215365, ANDA207739, ANDA071413 +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 |
|---|---|---|---|
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 55150-267-05 | EugiaIndia | 17 October 2017 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 68083-476-01 | Gland PharmaIndia | 30 March 2023 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 72205-100-01 | Novadoz PharmaceuticalsIndia | 23 November 2023 |
| 1 vial in 1 carton / 5 mL in 1 vial | 42023-129-01 | Par Health | 9 July 2014 |
| 1 vial in 1 carton / 5 mL in 1 vial | 42023-129-89 | Par Health | 26 June 2018 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 63323-272-05 | Fresenius Kabi | 15 December 2010 |
| 1 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 0143-9529-01 | Hikma Pharmaceuticals | 30 August 1996 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 67457-359-59 | Mylan Institutional | 28 September 2018 |
| 1 vial in 1 carton / 5 mL in 1 vial | 25021-838-05 | Sagent Pharmaceuticals | 1 August 2023 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 72162-2635-2 | Bryant Ranch Prepack | 6 May 2026 |
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 20 June 1972 | 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
Clinical summary
Fluphenazine decanoate is a phenothiazine. It is available as injection for intramuscular and subcutaneous use. MedsAcross supplies Fluphenazine decanoate 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 Fluphenazine decanoateFor 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 Decanoate prescribing information (Par Health) · U.S. National Library of Medicine, DailyMed
Need Fluphenazine decanoate 125 mg/5 mL injection 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.