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Tasimelteon

Active substance: tasimelteon

CAPSULE · TASIMELTEON 20 mg/1

United StatesActive

Marketing holder: Amneal Pharmaceuticals NY LLC

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Hetlioz
    tasimelteon
    EMEA/H/C/003870
    Vanda Pharmaceuticals Netherlands B.V.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-18be-7e47-a269-36bf3c53630d,01a1208e-fde3-7a6a-adf4-7714b09a3bac,01a12094-8f54-7322-9ac7-29bbbea67f78,01a12096-7a4d-7234-bc21-0bc6714342e4,01a1209d-5343-7183-8e00-eb0e351b4c5d;count=5 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
69238-2548
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 69238-2548 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 69238-2548 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 69238-2548 · Verified 2026-10-09 · open in source