Medicine
Rexulti 0.5 mg tablet
Rexulti 0.5 mg tablet is a prescription medicine containing Brexpiprazole for oral use, marketed by Otsuka America Pharmaceutical, 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 REXULTI tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Brexpiprazole
- Brand
- Rexulti
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Otsuka America Pharmaceutical
- Manufacturer
- Otsuka America Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store REXULTI tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05AX16 Brexpiprazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 July 2015
- Identifiers
- RxCUI 1658319, 1658325, 1658327 +7DailyMed set ID 2d301358-6291-4ec1-bd87-37b4ad9bd850NDC 59148-036Application NDA205422
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 30 tablet in 1 bottle | 59148-036-13 | Otsuka America Pharmaceutical | 10 July 2015 |
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.
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 Brexpiprazole 0.5 mg tablet.
Other strengths and forms of Brexpiprazole
Clinical summary
Brexpiprazole is an atypical antipsychotic indicated for adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults, among other approved uses. It is available as tablets and kits for oral use. MedsAcross supplies Brexpiprazole 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 BrexpiprazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rexulti prescribing information (Otsuka America Pharmaceutical) · U.S. National Library of Medicine, DailyMed
- Rxulti: European public assessment report (EPAR) · European Medicines Agency
Need Rexulti 0.5 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.