"64850-514-01" National Drug Code (NDC)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64850-514-01)
(Elite Laboratories, Inc.)

NDC Code64850-514-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64850-514-01)
Product NDC64850-514
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 NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Strength6.25; 6.25; 6.25; 6.25
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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