Medicine
Haloperidol decanoate 50 mg/1 mL injection
Haloperidol decanoate 50 mg/1 mL injection is a generic prescription medicine for intramuscular use, made by 13 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
Do not refrigerate or freeze. Store at 20º to 25ºC (68º to 77ºF), excursions…
Key facts
- Active ingredient (INN)
- Haloperidol decanoate
- Brand
- Sold under the generic name
- Strength
- 50 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 10 vials of 1 mL, 3 vials of 1 mL, 1 vial of 1 mL and 22 more
- Manufacturers
- Zydus LifesciencesIndiaLifestar PharmaIndiaCaplin SterilesIndiaGland PharmaIndiaSomerset TherapeuticsBluePoint LaboratoriesRemedyrepackArmas PharmaceuticalsFresenius KabiMeitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate or freeze. Store at 20º to 25ºC (68º to 77ºF), excursions permitted between 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 February 2000
- Identifiers
- RxCUI 859871, 1719803, 1719862 +1DailyMed set ID f2d14406-2ad4-4c5b-9c24-a026f27b415d, 8a96195e-97cd-4161-96e0-494a1636fa9c, 14f40303-9604-4a30-8e86-8abaeb177ce1 +14NDC 68001-578, 70756-615, 71288-502 +16Application ANDA209101, ANDA216730, ANDA214507 +6
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70710-1461-6 | Zydus LifesciencesIndia | 14 November 2019 |
| 3 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70710-1461-9 | Zydus LifesciencesIndia | 14 November 2019 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70771-1851-6 | Zydus LifesciencesIndia | 14 November 2019 |
| 3 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70771-1851-9 | Zydus LifesciencesIndia | 14 November 2019 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 65145-168-10 | Caplin SterilesIndia | 26 May 2025 |
| 10 vial in 1 carton / 1 mL in 1 vial | 68083-137-10 | Gland PharmaIndia | 16 January 2017 |
| 10 vial in 1 carton / 1 mL in 1 vial | 70756-615-10 | Lifestar PharmaIndia | 23 May 2023 |
| 3 vial in 1 carton / 1 mL in 1 vial | 70756-615-33 | Lifestar PharmaIndia | 23 May 2023 |
| 1 vial in 1 carton / 1 mL in 1 vial | 70756-615-81 | Lifestar PharmaIndia | 23 May 2023 |
| 3 ampule in 1 carton / 1 mL in 1 ampule | 70069-030-03 | Somerset Therapeutics | 3 July 2018 |
| 5 ampule in 1 carton / 1 mL in 1 ampule | 70069-030-05 | Somerset Therapeutics | 3 July 2018 |
| 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70069-381-01 | Somerset Therapeutics | 4 October 2019 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70069-381-10 | Somerset Therapeutics | 4 April 2019 |
| 10 vial in 1 carton / 1 mL in 1 vial | 70069-866-10 | Somerset Therapeutics | 29 September 2025 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 72485-520-10 | Armas Pharmaceuticals | 15 May 2026 |
| 1 vial in 1 carton / 1 mL in 1 vial | 63323-469-01 | Fresenius Kabi | 16 February 2000 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 71288-502-02 | Meitheal Pharmaceuticals | 26 July 2021 |
| 10 vial in 1 carton / 1 mL in 1 vial | 67457-410-13 | Mylan Institutional | 23 April 2013 |
| 3 ampule in 1 box / 1 mL in 1 ampule | 10147-0921-3 | Patriot Pharmaceuticals | 17 June 2011 |
| 10 vial in 1 carton / 1 mL in 1 vial | 25021-831-01 | Sagent Pharmaceuticals | 15 November 2017 |
| 3 ampule in 1 carton / 1 mL in 1 ampule | 68001-578-48 | BluePoint Laboratories | 15 September 2023 |
| 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 68001-580-41 | BluePoint Laboratories | 31 July 2023 |
| 3 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 68001-657-51 | BluePoint Laboratories | 1 October 2025 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70518-3743-0 | Remedyrepack | 2 June 2023 |
| 10 vial in 1 carton / 1 mL in 1 vial | 70518-4670-0 | Remedyrepack | 29 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 14 January 1986 | 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 Haloperidol decanoate
Clinical summary
Haloperidol decanoate is a typical antipsychotic indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. It is available as injection for intramuscular use. MedsAcross supplies Haloperidol 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 Haloperidol 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
- Haloperidol Decanoate prescribing information (Patriot Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Haloperidol decanoate 50 mg/1 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.