"0406-5127-01" National Drug Code (NDC)

Lisdexamfetamine Dimesylate 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5127-01)
(SpecGx LLC)

NDC Code0406-5127-01
Package Description100 TABLET, CHEWABLE in 1 BOTTLE (0406-5127-01)
Product NDC0406-5127
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLisdexamfetamine Dimesylate
Non-Proprietary NameLisdexamfetamine Dimesylate
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20241217
Marketing Category NameANDA
Application NumberANDA218850
ManufacturerSpecGx LLC
Substance NameLISDEXAMFETAMINE DIMESYLATE
Strength40
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII

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