Medicine
Tasimelteon 20 mg capsule
Tasimelteon 20 mg capsule is a generic prescription medicine for oral use, made by 3 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 tasimelteon 20 mg capsules at controlled room temperature, 20°C to 25°C…
Key facts
- Active ingredient (INN)
- Tasimelteon
- Brand
- Sold under the generic name
- Strength
- 20 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 90 capsules and 1 more
- Manufacturers
- ApotexAmneal Pharmaceuticals NYTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store tasimelteon 20 mg capsules at controlled room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from exposure to light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05CH03 Tasimelteon
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 December 2022
- Identifiers
- RxCUI 1490473DailyMed set ID 99cb1928-e57d-4d04-87a1-38108780598a, 46b09064-a675-92d5-24a7-dac0410f77ae, ce5a2fa3-ed54-422d-96c2-1821496eb32fNDC 69238-2548, 60505-4665, 0480-4490Application ANDA211654, ANDA211607, ANDA211601
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 |
|---|---|---|---|
| 30 capsule in 1 bottle | 69238-2548-3 | Amneal Pharmaceuticals NY | 24 February 2023 |
| 30 capsule in 1 bottle | 60505-4665-3 | Apotex | 5 January 2024 |
| 90 capsule in 1 bottle | 60505-4665-9 | Apotex | 5 January 2024 |
| 30 capsule, gelatin coated in 1 bottle | 0480-4490-56 | Teva Pharmaceuticals | 29 December 2022 |
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 Tasimelteon 20 mg capsule.
Other strengths and forms of Tasimelteon
Clinical summary
Tasimelteon is a melatonin receptor agonist indicated for the treatment of non-24-Hour Sleep-Wake Disorder (Non-24) in adults, among other approved uses. It is available as capsules and oral suspension. MedsAcross supplies Tasimelteon 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 TasimelteonFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hetlioz prescribing information (Vanda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Hetlioz: European public assessment report (EPAR) · European Medicines Agency
Need Tasimelteon 20 mg capsule 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.