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Spravato

Active substance: esketamine

SOLUTION · ESKETAMINE HYDROCHLORIDE 28 mg/.2mL

United StatesActive

Marketing holder: Janssen 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
  • Spravato
    esketamine hydrochloride
    EMEA/H/C/004535
    Janssen-Cilag International NV
Import and control

Control by country

  • United StatescontrolledSchedule: CIII

    Source: openFDA NDC · record 01a1209d-6f9e-73d0-bce4-8a2f5dc64297;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
50458-028
Registration status
Active
Dispensing
Prescription only
Control marker
CIII
Route
NASAL
Sources
  • product · openFDA NDC · 50458-028 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 50458-028 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 50458-028 · Verified 2026-10-09 · open in source