"0115-1682-01" National Drug Code (NDC)

Dexmethylphenidate Hydrochloride 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1682-01)
(Amneal Pharmaceuticals of New York LLC)

NDC Code0115-1682-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1682-01)
Product NDC0115-1682
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmethylphenidate Hydrochloride
Non-Proprietary NameDexmethylphenidate Hydrochloride
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150806
Marketing Category NameANDA
Application NumberANDA079108
ManufacturerAmneal Pharmaceuticals of New York LLC
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Strength5
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII

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