NDC 50458-596

Risperidone 1 mg per 1 mL solution

On the label: Janssen Pharmaceuticals, Inc..

Belgium: 2Ireland: 1Portugal: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Janssen Pharmaceutica NVBeerse, BelgiumMakes it and tests it Problems found, fixed voluntarilySep 5, 2025 · 8 inspections
Janssen Pharmaceutica NVGeel, BelgiumMakes the active ingredient Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections
Janssen Pharmaceutical Sciences Unlimited CompanyCo Cork, IrelandMakes the active ingredient Problems found, fixed voluntarilyOct 27, 2023 · 5 inspections
Lusomedicamenta - Sociedade Tecnica Farmaceutica, S.a.Queluz de Baixo, PortugalMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyOct 18, 2024 · 2 inspections

Product details

Generic drug
Risperidone: every company that makes it
Form
solution, oral
Strength
1 mg per 1 mL
Approval
NDA NDA020588
On the market since
Jun 10, 1996
Package NDCs
50458-596-01
Official label
DailyMed (National Library of Medicine), updated Aug 20, 2026

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