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Buphenyl

Active substance: sodium phenylbutyrate

POWDER · SODIUM PHENYLBUTYRATE .94 g/g

United StatesActive

Marketing holder: Horizon Therapeutics USA, 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 3
  • Albrioza
    sodium phenylbutyrate, ursodoxicoltaurine
    EMEA/H/C/005901
    Amylyx Pharmaceuticals EMEA B.V.
  • Ammonaps
    sodium phenylbutyrate
    EMEA/H/C/000219
    Immedica Pharma AB
  • Pheburane
    sodium phenylbutyrate
    EMEA/H/C/002500
    Eurocept International B. V.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-3094-711a-a85f-ed7c1bf26f0b,01a1208e-5599-70e6-9a81-df11657d1378,01a1208f-09b1-7f86-8882-4de0c99e8e3a,01a1208f-09b6-7029-b974-15284f2c4393,01a1208f-108c-7a65-a16f-c6775ff786bd;count=15 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
75987-070
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 75987-070 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 75987-070 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 75987-070 · Verified 2026-10-09 · open in source