"0078-0430-05" National Drug Code (NDC)

Focalin 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05)
(Novartis Pharmaceuticals Corporation)

NDC Code0078-0430-05
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05)
Product NDC0078-0430
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFocalin
Proprietary Name SuffixXr
Non-Proprietary NameDexmethylphenidate Hydrochloride
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20050531
Marketing Category NameNDA
Application NumberNDA021802
ManufacturerNovartis Pharmaceuticals Corporation
Substance NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Strength5
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII

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