Medicine
Iloperidone 4 mg tablet
Iloperidone 4 mg tablet is a generic prescription medicine for oral use, 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 Iloperidone tablets at controlled room temperature, 25°C (77°F)…
Key facts
- Active ingredient (INN)
- Iloperidone
- Brand
- Sold under the generic name
- Strength
- 4 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 10 blister pack, 60 tablets
- Manufacturer
- Mylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store Iloperidone tablets at controlled room temperature, 25°C (77°F), excursions permitted to 15° to 30 °C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05AX14 Iloperidone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 March 2017
- Identifiers
- RxCUI 848722, 848728, 848732 +4DailyMed set ID eeb0fcfd-e4e8-4fb1-9635-901dc9446235NDC 0378-0632Application ANDA207231
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 0378-0632-01 | Mylan Pharmaceuticals | 20 March 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 0378-0632-88 | Mylan Pharmaceuticals | 20 March 2017 |
| 60 tablet in 1 bottle | 0378-0632-91 | Mylan Pharmaceuticals | 20 March 2017 |
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 6 May 2009 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| 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 Iloperidone 4 mg tablet.
Other strengths and forms of Iloperidone
Clinical summary
Iloperidone is an atypical antipsychotic indicated for treatment of schizophrenia in adults. It is available as tablets and kits for oral use. MedsAcross supplies Iloperidone 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 IloperidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FANAPT prescribing information (Vanda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Iloperidone 4 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.