NDC 50458-588

Concerta 27 mg tablet, extended release

On the label: Janssen Pharmaceuticals, Inc..

United States: 2

Where it's made

FactoryWhereRoleLast FDA inspection
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 and tests it Problems found, fixed voluntarilyFeb 11, 2026 · 6 inspections
AndersonBrecon Inc.Rockford, IL, United StatesPackages it No problems foundAug 19, 2026 · 11 inspections
Janssen Ortho LLCGurabo, PR, United StatesTests it and packages it Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections
Janssen Pharmaceuticals Inc.Raritan, NJ, United StatesTests it No problems foundJun 17, 2022 · 8 inspections
Janssen Pharmaceuticals, Inc.Titusville, NJ, United StatesTests it Problems found, fixed voluntarilySep 25, 2026 · 11 inspections

Product details

Generic drug
Methylphenidate: every company that makes it
Form
tablet, extended release, oral
Strength
27 mg
Approval
NDA NDA021121
On the market since
Aug 1, 2000
Package NDCs
50458-588-01
Official label
DailyMed (National Library of Medicine), updated Apr 20, 2026

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