"0378-4082-01" National Drug Code (NDC)

Dexmethylphenidate Hydrochloride 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4082-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4082-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4082-01)
Product NDC0378-4082
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmethylphenidate Hydrochloride
Non-Proprietary NameDexmethylphenidate Hydrochloride
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150826
Marketing Category NameANDA
Application NumberANDA204266
ManufacturerMylan Pharmaceuticals Inc.
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Strength15
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII

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