"72028-045-03" National Drug Code (NDC)

Wakix 1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
(Harmony Biosciences, LLC)

NDC Code72028-045-03
Package Description1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product NDC72028-045
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameWakix
Non-Proprietary NamePitolisant Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20190814
Marketing Category NameNDA
Application NumberNDA211150
ManufacturerHarmony Biosciences, LLC
Substance NamePITOLISANT HYDROCHLORIDE
Strength4.45
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 3A4 Inducers [MoA], Histamine H3 Receptor Antagonists [MoA], Histamine H3 Receptor Inverse Agonists [MoA], Histamine-3 Receptor Antagonist/Inverse Agonist [EPC]

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