"42858-610-01" National Drug Code (NDC)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-610-01)
(Rhodes Pharmaceuticals L.P.)

NDC Code42858-610-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-610-01)
Product NDC42858-610
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release
Non-Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20190822
Marketing Category NameANDA
Application NumberANDA210651
ManufacturerRhodes Pharmaceuticals L.P.
Substance NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Strength2.5; 2.5; 2.5; 2.5
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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