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Valsartan

Active substance: valsartan

TABLET · VALSARTAN 160 mg/1

United StatesActive

Marketing holder: Amneal Pharmaceuticals of New York 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
EU 11
  • Amlodipine / Valsartan Mylan
    amlodipine besilate, valsartan
    EMEA/H/C/004037
    Mylan Pharmaceuticals Limited
  • Copalia
    valsartan, amlodipine (as amlodipine besilate)
    EMEA/H/C/000774
    Novartis Europharm Limited
  • Copalia HCT
    amlodipine, valsartan, hydrochlorothiazide
    EMEA/H/C/001159
    Novartis Europharm Limited
  • Dafiro
    amlodipine, valsartan
    EMEA/H/C/000776
    Novartis Europharm Limited
  • Dafiro HCT
    valsartan, hydrochlorothiazide, amlodipine besilate
    EMEA/H/C/001160
    Novartis Europharm Limited
All products in this country (11)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-29af-7079-b0db-c9a33a62cd49,01a1208c-2ba5-75cf-992d-cf9fee14e9aa,01a1208c-2d7a-75b1-95d8-a7cc04d38e1d,01a1208c-4f53-7977-a9fa-a880fbb1ccb5,01a1208c-6a7e-7bd0-a7c4-9fd98e75485c;count=140 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
53746-839
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 53746-839 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 53746-839 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 53746-839 · Verified 2026-10-09 · open in source