"70518-0714-0" National Drug Code (NDC)

NDC Code	70518-0714-0
Package Description	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0714-0)
Product NDC	70518-0714
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Prezcobix
Non-Proprietary Name	Darunavir Ethanolate And Cobicistat
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20170828
Marketing Category Name	NDA
Application Number	NDA205395
Manufacturer	REMEDYREPACK INC.
Substance Name	DARUNAVIR ETHANOLATE; COBICISTAT
Strength	800; 150
Strength Unit	mg/1; mg/1
Pharmacy Classes	HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]