Medicine
Lybalvi 5 mg/10 mg tablet
Lybalvi 5 mg/10 mg tablet is a prescription medicine containing Olanzapine and Samidorphan l-malate for oral use, marketed by Alkermes, 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 room temperature 20°C to 25°C (68°F to 77°F) with excursions…
Key facts
- Active ingredient (INN)
- Olanzapine and Samidorphan l-malate
- Brand
- Lybalvi
- Strength
- 5 mg/10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Alkermes
- Manufacturer
- Alkermes
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep tightly closed and protect from moisture.
- 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
- 20 September 2021
- Identifiers
- RxCUI 2570392, 2570398, 2570399 +5DailyMed set ID 32ffddd1-4e2b-45d9-9b36-bb730167ec80NDC 65757-651Application NDA213378
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, film coated in 1 bottle | 65757-651-42 | Alkermes | 20 September 2021 |
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 28 May 2021 | 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 Olanzapine and Samidorphan l-malate
Clinical summary
Olanzapine and Samidorphan l-malate is a fixed-dose combination of an atypical antipsychotic and an opioid antagonist. It is available as tablets for oral use. MedsAcross supplies Olanzapine and Samidorphan l-malate 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 Olanzapine and Samidorphan l-malateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LYBALVI prescribing information (Alkermes) · U.S. National Library of Medicine, DailyMed
Need Lybalvi 5 mg/10 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.