Medicine
Haloperidol 5 mg tablet
Haloperidol 5 mg tablet is a generic prescription medicine for oral use, made by 23 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Haloperidol
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 49 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaLifestar PharmaIndiaNovadoz PharmaceuticalsIndiaAjanta PharmaIndiaRemedyrepackBryant Ranch PrepackCreekwood PharmaceuticalsMethod PharmaceuticalsAiPing Pharmaceutical23 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 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
- ATC code
- N05AD01 Haloperidol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 June 1986
- Identifiers
- RxCUI 197754, 310670, 310671 +3DailyMed set ID 9763c044-7430-48f7-bf3e-da1c7c683955, afb3ac3e-7459-42d3-b5ca-e0d6d27ced73, ad7d2f17-a4e8-4ebc-9baf-5983ac626782 +31NDC 82619-108, 0832-1540, 51079-736 +32Application ANDA218162, ANDA211061, ANDA070278 +7
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 23 labelers. The register lists 52 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 65841-626-01 | Zydus LifesciencesIndia | 3 January 2008 |
| 1000 tablet in 1 bottle | 65841-626-10 | Zydus LifesciencesIndia | 3 January 2008 |
| 100 tablet in 1 bottle | 68382-079-01 | Zydus LifesciencesIndia | 3 January 2008 |
| 1000 tablet in 1 bottle | 68382-079-10 | Zydus LifesciencesIndia | 3 January 2008 |
| 100 tablet in 1 bottle | 27241-267-01 | Ajanta PharmaIndia | 14 September 2026 |
| 100 tablet in 1 bottle | 59651-792-01 | Aurobindo PharmaIndia | 19 April 2024 |
| 1000 tablet in 1 bottle | 59651-792-99 | Aurobindo PharmaIndia | 19 April 2024 |
| 100 tablet in 1 bottle | 70756-004-11 | Lifestar PharmaIndia | 11 April 2024 |
| 1000 tablet in 1 bottle | 70756-004-12 | Lifestar PharmaIndia | 11 April 2024 |
| 100 tablet in 1 bottle | 72205-067-91 | Novadoz PharmaceuticalsIndia | 22 November 2022 |
| 1000 tablet in 1 bottle | 72205-067-99 | Novadoz PharmaceuticalsIndia | 22 November 2022 |
| 100 tablet in 1 bottle | 58657-703-01 | Method Pharmaceuticals | 25 November 2019 |
| 1000 tablet in 1 bottle | 58657-703-10 | Method Pharmaceuticals | 25 November 2019 |
| 100 tablet in 1 carton | 58657-903-01 | Method Pharmaceuticals | 5 June 2025 |
| 100 tablet in 1 bottle | 11788-074-01 | AiPing Pharmaceutical | 8 April 2026 |
| 1000 tablet in 1 bottle | 11788-074-10 | AiPing Pharmaceutical | 8 April 2026 |
| 100 tablet in 1 bottle | 69292-586-01 | Amici Pharmaceuticals | 18 April 2022 |
| 1000 tablet in 1 bottle | 69292-586-10 | Amici Pharmaceuticals | 18 April 2022 |
| 30 tablet in 1 bottle | 82619-108-01 | Creekwood Pharmaceuticals | 5 January 2026 |
| 100 tablet in 1 bottle | 82619-108-02 | Creekwood Pharmaceuticals | 5 January 2026 |
| 1000 tablet in 1 bottle | 82619-108-03 | Creekwood Pharmaceuticals | 5 January 2026 |
| 100 tablet in 1 bottle | 71247-153-01 | Innogenix | 18 February 2021 |
| 1000 tablet in 1 bottle | 71247-153-10 | Innogenix | 18 February 2021 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 51079-736-20 | Mylan Institutional | 15 February 2004 |
| 1000 tablet in 1 bottle, plastic | 0378-0327-10 | Mylan Pharmaceuticals | 10 June 1986 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0832-1540-01 | Upsher-Smith Laboratories | 30 September 2022 |
| 100 tablet in 1 bottle | 0832-1540-11 | Upsher-Smith Laboratories | 13 January 2020 |
| 100 tablet in 1 bottle | 63629-9273-1 | Bryant Ranch Prepack | 18 April 2022 |
| 1000 tablet in 1 bottle | 63629-9274-1 | Bryant Ranch Prepack | 18 April 2022 |
| 100 tablet in 1 bottle | 71335-2912-1 | Bryant Ranch Prepack | 29 October 2025 |
| 1000 tablet in 1 bottle | 72162-1686-0 | Bryant Ranch Prepack | 11 January 2024 |
| 100 tablet in 1 bottle | 72162-1686-1 | Bryant Ranch Prepack | 11 January 2024 |
| 100 tablet in 1 bottle | 72162-2624-1 | Bryant Ranch Prepack | 21 April 2026 |
| 30 tablet in 1 blister pack | 70518-1182-0 | Remedyrepack | 14 May 2018 |
| 30 tablet in 1 blister pack | 70518-1269-0 | Remedyrepack | 19 June 2018 |
| 30 tablet in 1 blister pack | 70518-3608-0 | Remedyrepack | 4 January 2023 |
| 30 tablet in 1 blister pack | 70518-3608-1 | Remedyrepack | 19 September 2023 |
| 100 pouch in 1 box / 1 tablet in 1 pouch | 70518-3608-2 | Remedyrepack | 5 January 2026 |
| 30 tablet in 1 blister pack | 70518-4285-0 | Remedyrepack | 11 February 2025 |
| 100 pouch in 1 box / 1 tablet in 1 pouch | 70518-4285-1 | Remedyrepack | 31 August 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 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 5 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.