"0378-1071-01" National Drug Code (NDC)

Dextroamphetamine Sulfate 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-1071-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1071-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-1071-01)
Product NDC0378-1071
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDextroamphetamine Sulfate
Non-Proprietary NameDextroamphetamine
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20160720
End Marketing Date20190731
Marketing Category NameANDA
Application NumberANDA206735
ManufacturerMylan Pharmaceuticals Inc.
Substance NameDEXTROAMPHETAMINE SULFATE
Strength10
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII

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