Medicine
Haloperidol 50 mg/10 mL injection
Haloperidol 50 mg/10 mL injection is a generic prescription medicine for intramuscular use, made by 2 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 freeze. Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Haloperidol
- Brand
- Sold under the generic name
- Strength
- 50 mg/10 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 1 vial of 10 mL
- Manufacturers
- Fresenius KabiHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. 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
- N05AD01 Haloperidol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 October 2000
- Identifiers
- RxCUI 204416, 1719646DailyMed set ID 8397a841-f240-4767-9dcd-781e6d3f7c7f, b1ad2abd-a9d6-44e3-957b-36a73260f4f5NDC 0143-9502, 63323-474Application ANDA075858, ANDA075689
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 box / 10 mL in 1 vial, multi-dose | 63323-474-10 | Fresenius Kabi | 20 October 2000 |
| 1 vial in 1 box / 10 mL in 1 vial | 0143-9502-01 | Hikma Pharmaceuticals | 19 June 2001 |
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 12 April 1967 | 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
Clinical summary
Haloperidol is a typical antipsychotic indicated for the treatment of patients with schizophrenia. It is available as tablets, injection and oral solution for intramuscular use. MedsAcross supplies Haloperidol 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 HaloperidolFor 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 prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Haloperidol 50 mg/10 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.