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Kalydeco

Active substance: ivacaftor

GRANULE · IVACAFTOR 50 mg/1

United StatesActive

Marketing holder: Vertex Pharmaceuticals Incorporated

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 4
  • Kaftrio
    ivacaftor, tezacaftor, elexacaftor
    EMEA/H/C/005269
    Vertex Pharmaceuticals (Ireland) Limited
  • Kalydeco
    ivacaftor
    EMEA/H/C/002494
    Vertex Pharmaceuticals (Ireland) Limited
  • Orkambi
    Lumacaftor, ivacaftor
    EMEA/H/C/003954
    Vertex Pharmaceuticals (Ireland) Limited
  • Symkevi
    tezacaftor, ivacaftor
    EMEA/H/C/004682
    Vertex Pharmaceuticals (Ireland) Limited
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-6d6d-75dc-bc9a-3dc2d4a7db3a,01a1208d-349f-73cc-ac9e-4b3179201d08,01a1208e-641c-74cc-a539-688a62fb860b,01a1208e-6426-754f-9879-db0948bd2584,01a12091-bdba-75b8-8f00-3f6ec295657b;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
51167-300
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 51167-300 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 51167-300 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 51167-300 · Verified 2026-10-09 · open in source