"68382-955-01" National Drug Code (NDC)

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate 100 TABLET in 1 BOTTLE (68382-955-01)
(Zydus Pharmaceuticals (USA) Inc.)

NDC Code68382-955-01
Package Description100 TABLET in 1 BOTTLE (68382-955-01)
Product NDC68382-955
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Non-Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Dosage FormTABLET
UsageORAL
Start Marketing Date20171031
Marketing Category NameANDA
Application NumberANDA207340
ManufacturerZydus Pharmaceuticals (USA) Inc.
Substance NameAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE
Strength5; 5; 5; 5
Strength Unitmg/1; mg/1; mg/1; mg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII

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