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DEFITELIO

Active substance: defibrotide

INJECTION, SOLUTION · DEFIBROTIDE SODIUM 80 mg/mL

United StatesActive

Marketing holder: Jazz 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
  • Defitelio
    defibrotide
    EMEA/H/C/002393
    Gentium S.r.l.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12094-794c-702f-8737-db3610561d67;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
68727-800
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 68727-800 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 68727-800 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 68727-800 · Verified 2026-10-09 · open in source