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DARIFENACIN

Active substance: darifenacin

TABLET, EXTENDED RELEASE · DARIFENACIN HYDROBROMIDE 15 mg/1

United StatesActive

Marketing holder: Alembic 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
  • Emselex
    darifenacin hydrobromide
    EMEA/H/C/000554
    pharmaand GmbH
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-c6a4-7252-95d5-ce4ed984c017,01a1208e-c4c8-70f8-9f03-820014185c2c,01a1208f-920f-7d89-bae0-0a24331279e3,01a12094-4093-78c3-ae12-5be998716c76,01a12097-39ab-7c1e-adcc-159d81b024e3;count=16 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
62332-224
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 62332-224 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 62332-224 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 62332-224 · Verified 2026-10-09 · open in source