NDC 61958-1803

Harvoni

Ledipasvir And Sofosbuvir

Harvoni is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc. The primary component is Ledipasvir; Sofosbuvir.

Product ID61958-1803_6122d2f4-19e4-4aae-89ce-bef7bfc5cb3e
NDC61958-1803
Product TypeHuman Prescription Drug
Proprietary NameHarvoni
Generic NameLedipasvir And Sofosbuvir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-08-28
Marketing CategoryNDA / NDA
Application NumberNDA205834
Labeler NameGilead Sciences, Inc
Substance NameLEDIPASVIR; SOFOSBUVIR
Active Ingredient Strength45 mg/1; mg/1
Pharm ClassesHepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 61958-1803-1

28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)
Marketing Start Date2019-08-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61958-1803-1 [61958180301]

Harvoni TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205834
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-28

Drug Details

Active Ingredients

IngredientStrength
LEDIPASVIR45 mg/1

OpenFDA Data

SPL SET ID:f4ec77e4-bae8-4db0-b3d5-bde09c5fa075
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2203895
  • 2203897
  • 1591949
  • 1591943
  • 2204104
  • 2204102
  • 2204103
  • 2204100
  • UPC Code
  • 0361958180313
  • 0361958180115
  • Pharmacological Class

    • Hepatitis C Virus NS5A Inhibitor [EPC]
    • P-Glycoprotein Inhibitors [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]
    • Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]
    • RNA Replicase Inhibitors [MoA]
    • Nucleoside Analog [EXT]

    NDC Crossover Matching brand name "Harvoni" or generic name "Ledipasvir And Sofosbuvir"

    NDCBrand NameGeneric Name
    61958-1801HarvoniLEDIPASVIR and SOFOSBUVIR
    61958-1803Harvoniledipasvir and sofosbuvir
    61958-1804Harvoniledipasvir and sofosbuvir
    61958-1805Harvoniledipasvir and sofosbuvir
    72626-2601Ledipasvir and SofosbuvirLedipasvir and Sofosbuvir

    Trademark Results [Harvoni]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HARVONI
    HARVONI
    86095994 4608545 Live/Registered
    GILEAD SCIENCES IRELAND UC
    2013-10-18

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