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URELLE

Active substance: HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET · HYOSCYAMINE SULFATE .12 mg/1, METHENAMINE 81 mg/1, METHYLENE BLUE 10.8 mg/1, PHENYL SALICYLATE 32.4 mg/1, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg/1

United StatesActive

Marketing holder: Viatris Specialty LLC

Verified 2026-10-09 · openFDA NDC

Composition
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-754b-735a-bfdb-e788425d211e,01a1208c-7f0b-734b-8907-93447749b455,01a1208c-8a8f-7044-9f4d-33663cd5fced,01a1208c-9218-7d56-80aa-c83f8f95495d,01a1208c-92d8-7764-9fea-f271cd2e1a8b;count=55 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0037-6321
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 0037-6321 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0037-6321 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0037-6321 · Verified 2026-10-09 · open in source
  • ingredients.1 · openFDA NDC · 0037-6321 · Verified 2026-10-09 · open in source
  • ingredients.2 · openFDA NDC · 0037-6321 · Verified 2026-10-09 · open in source
  • ingredients.3 · openFDA NDC · 0037-6321 · Verified 2026-10-09 · open in source
  • ingredients.4 · openFDA NDC · 0037-6321 · Verified 2026-10-09 · open in source