"0115-1569-01" National Drug Code (NDC)

Methylphenidate Hydrochloride 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-1569-01)
(Impax Generics)

NDC Code0115-1569-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-1569-01)
Product NDC0115-1569
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMethylphenidate Hydrochloride
Non-Proprietary NameMethylphenidate Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20180330
Marketing Category NameANDA
Application NumberANDA208607
ManufacturerImpax Generics
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Strength54
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII

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