"0378-8157-01" National Drug Code (NDC)

Methylphenidate Hydrochloride 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8157-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-8157-01
Package Description100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8157-01)
Product NDC0378-8157
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMethylphenidate Hydrochloride
Non-Proprietary NameMethylphenidate Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20161229
End Marketing Date20221031
Marketing Category NameANDA
Application NumberANDA206726
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Strength36
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII

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