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Orladeyo

Active substance: berotralstat

PELLET · BEROTRALSTAT HYDROCHLORIDE 108 mg/1

United StatesActive

Marketing holder: BioCryst Pharmaceuticals, Inc.

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
  • Orladeyo
    berotralstat dihydrochloride
    EMEA/H/C/005138
    Neopharmed Gentili Ireland Limited
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2cf5-7456-995b-a93f6331f91e,01a1208c-ccd4-7915-83c6-318d47c95e58,01a1208d-bd25-7f15-9ae9-f2d700a8ee57,01a12092-b091-721e-89ae-0f9f2d8198f6,01a12099-d0b3-7619-b1a3-60af8b354c6a;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
72769-113
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 72769-113 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 72769-113 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 72769-113 · Verified 2026-10-09 · open in source