"63539-927-01" National Drug Code (NDC)

Lorbrena 30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)
(U.S. Pharmaceuticals)

NDC Code63539-927-01
Package Description30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)
Product NDC63539-927
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLorbrena
Non-Proprietary NameLorlatinib
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20230103
Marketing Category NameNDA
Application NumberNDA210868
ManufacturerU.S. Pharmaceuticals
Substance NameLORLATINIB
Strength25
Strength Unitmg/1
Pharmacy ClassesBreast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inducers [MoA]

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