"54092-477-01" National Drug Code (NDC)

Mydayis 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-477-01)
(Takeda Pharmaceuticals America, Inc.)

NDC Code54092-477-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-477-01)
Product NDC54092-477
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMydayis
Non-Proprietary NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20170620
Marketing Category NameNDA
Application NumberNDA022063
ManufacturerTakeda Pharmaceuticals America, Inc.
Substance NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Strength12.5; 12.5; 12.5; 12.5
Strength Unitmg/1; mg/1; mg/1; mg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA ScheduleCII

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