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HEPCLUDEX

Active substance: bulevirtide

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · BULEVIRTIDE ACETATE 8.5 mg/1

United StatesActive

Marketing holder: Gilead Sciences, 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
  • Hepcludex
    bulevirtide acetate
    EMEA/H/C/004854
    Gilead Sciences Ireland UC
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-971b-72b1-8a31-15c2d46fed06;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
61958-3104
Registration status
Active
Dispensing
Prescription only
Route
SUBCUTANEOUS
Sources
  • product · openFDA NDC · 61958-3104 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 61958-3104 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 61958-3104 · Verified 2026-10-09 · open in source