NDC 50458-028

Spravato 28 mg per 0.2 mL solution

On the label: Janssen Pharmaceuticals, Inc..

United States: 3Germany: 1Belgium: 1

Where it's made

FactoryWhereRoleLast FDA inspection
CU Chemie Uetikon GmbHLahr, GermanyMakes the active ingredient and tests it Problems found, fixed voluntarilyJan 30, 2025 · 6 inspections
Janssen Pharmaceutica NVGeel, BelgiumMakes the active ingredient Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections
Janssen Pharmaceuticals, Inc.Athens, GA, United StatesMakes the active ingredient Problems found, fixed voluntarilyJan 24, 2025 · 5 inspections
Janssen-Cilag Manufacturing, LLCGurabo, PR, United StatesMakes it, tests it and packages it Problems found, fixed voluntarilyFeb 11, 2026 · 6 inspections
LTS Lakewood, LLCLakewood, NJ, United StatesMakes it, tests it and packages it Problems found, fixed voluntarilyJul 29, 2026 · 14 inspections, 1 with FDA action
Janssen Ortho LLCGurabo, PR, United StatesPackages it Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections
Janssen Pharmaceuticals Inc.Raritan, NJ, United StatesTests it No problems foundJun 17, 2022 · 8 inspections
PPD Development, L.P.Middleton, WI, United StatesTests it Problems found, fixed voluntarilySep 25, 2025 · 6 inspections

Product details

Generic drug
Esketamine: every company that makes it
Form
solution, nasal
Strength
28 mg per 0.2 mL
Approval
NDA NDA211243
On the market since
Mar 5, 2019
Package NDCs
50458-028-00 50458-028-02 50458-028-03
Official label
DailyMed (National Library of Medicine), updated Sep 22, 2026

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