"59676-800-30" National Drug Code (NDC)

Symtuza 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)
(Janssen Products LP)

NDC Code59676-800-30
Package Description30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)
Product NDC59676-800
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSymtuza
Non-Proprietary NameDarunavir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20180717
Marketing Category NameNDA
Application NumberNDA210455
ManufacturerJanssen Products LP
Substance NameCOBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
Strength150; 800; 200; 10
Strength Unitmg/1; mg/1; mg/1; mg/1
Pharmacy ClassesBreast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]

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