NDC 69616-211

Firdapse 10 mg tablet

On the label: Catalyst Pharmaceuticals, Inc..

United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Pharmaceutics International, Inc.Hunt Valley, MD, United StatesMakes it and tests it Problems found, fixed voluntarilyDec 6, 2024 · 14 inspections
Catalent Micron Technologies, Inc.Malvern, PA, United StatesTests it and mills it Problems found, fixed voluntarilyJun 9, 2025 · 7 inspections
PCI Pharma Services Canada, Inc.Mississauga, CanadaPackages it No problems foundFeb 28, 2025 · 3 inspections
Quality Chemical LaboratoriesWilmington, NC, United StatesTests it Problems found, fixed voluntarilyNov 20, 2024 · 5 inspections
Robertson Microlit Laboratories, Inc.Ledgewood, NJ, United StatesTests it No problems foundJan 11, 2024 · 5 inspections
SGS Canada IncMississauga, CanadaTests it No problems foundNov 15, 2023 · 7 inspections
SGS North America Inc.Lincolnshire, IL, United StatesTests it Problems found, fixed voluntarilyMar 20, 2026 · 9 inspections

Product details

Generic drug
Amifampridine: every company that makes it
Form
tablet, oral
Strength
10 mg
Approval
NDA NDA208078
On the market since
Jan 7, 2019
Package NDCs
69616-211-03 69616-211-04 69616-211-06 69616-211-08
Official label
DailyMed (National Library of Medicine), updated Apr 16, 2026

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