"70748-387-01" National Drug Code (NDC)

Pitolisant 1 BOTTLE in 1 CARTON (70748-387-01) / 30 TABLET, FILM COATED in 1 BOTTLE
(Lupin Pharmaceuticals, Inc.)

NDC Code70748-387-01
Package Description1 BOTTLE in 1 CARTON (70748-387-01) / 30 TABLET, FILM COATED in 1 BOTTLE
Product NDC70748-387
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePitolisant
Non-Proprietary NamePitolisant
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20261016
Marketing Category NameANDA
Application NumberANDA218846
ManufacturerLupin Pharmaceuticals, Inc.
Substance NamePITOLISANT HYDROCHLORIDE
Strength17.8
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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