"61958-1803-1" National Drug Code (NDC)

Harvoni 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)
(Gilead Sciences, Inc)

NDC Code61958-1803-1
Package Description28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)
Product NDC61958-1803
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHarvoni
Non-Proprietary NameLedipasvir And Sofosbuvir
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20190828
Marketing Category NameNDA
Application NumberNDA205834
ManufacturerGilead Sciences, Inc
Substance NameLEDIPASVIR; SOFOSBUVIR
Strength45; 200
Strength Unitmg/1; mg/1
Pharmacy ClassesBreast Cancer Resistance Protein Inhibitors [MoA], Hepatitis C Virus NS5A Inhibitor [EPC], Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], Nucleoside Analog [EXT], P-Glycoprotein Inhibitors [MoA], RNA Replicase Inhibitors [MoA]

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