"64850-513-01" National Drug Code (NDC)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64850-513-01)
(Elite Laboratories, Inc.)

NDC Code64850-513-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64850-513-01)
Product NDC64850-513
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 Date20191216
Marketing Category NameANDA
Application NumberANDA212037
ManufacturerElite Laboratories, Inc.
Substance NameDEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE
Strength5; 5; 5; 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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