"0480-3683-01" National Drug Code (NDC)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3683-01)
(Teva Pharmaceuticals, Inc.)

NDC Code0480-3683-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3683-01)
Product NDC0480-3683
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate
Non-Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20231010
Marketing Category NameANDA
Application NumberANDA210876
ManufacturerTeva Pharmaceuticals, Inc.
Substance NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Strength3.125; 3.125; 3.125; 3.125
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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