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Mysoline

Active substance: primidone

TABLET · PRIMIDONE 50 mg/1

United StatesActive

Marketing holder: Bausch Health US, LLC

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
RU 2
  • Примидон
    субстанция-порошок, ~, 50 кг (original in Russian, GRLS)
    ЛСР-009660/08
    Нантонг Джингхуа Фармасьютикал Ко.Лтд
  • Примидон
    таблетки, 250 мг (original in Russian, GRLS)
    Р N002876/01
    Открытое акционерное общество "Химико-фармацевтический комбинат "АКРИХИН" (ОАО "АКРИХИН")
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-3879-7b0f-b75c-63805aa4fb22,01a1208c-75db-7cdd-aefc-3d7f88932f8c,01a1208c-cc6f-797e-a443-2ab1b05cd455,01a1208c-d712-7aa0-a24c-ce00e1a0d5e1,01a1208d-785c-7357-86f2-3c27fd762d62;count=42 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
66490-690
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 66490-690 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 66490-690 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 66490-690 · Verified 2026-10-09 · open in source