61958-1803 : Harvoni Oral Tablet, Film Coated


NDC61958-1803
Labeler: Gilead Sciences, Inc
Product Type: Human Prescription Drug
Drug Name:  Harvoni
Dosage Form: Oral Tablet, Film Coated
Application #: NDA205834
Rev. Date: 


Appearance:


Markings: GSI;HRV
Shapes:  Oval
Colors:  White
Size (mm): 14
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 61958-1803-1: 28 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (61958‑1803‑1)

Active Ingredients:

  • Ledipasvir
  • Sofosbuvir

Dosage Strength:

  • 45 mg
  • 200 mg

Inactive Ingredients:

  • Alcohol
  • Copovidone K25-31
  • Lactose Monohydrate
  • Microcrystalline Cellulose
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Water
  • Titanium Dioxide
  • Polyethylene Glycol 3350
  • Talc
  • Polyvinyl Alcohol, Unspecified /

Pharmaceutical Classes:

  • 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]

Related Products:

Based on records with the same trade name.
  • 61958-1801 Harvoni Oral Tablet, Film Coated by Gilead Sciences, Inc
  • 61958-1804 Harvoni Oral Pellet by Gilead Sciences, Inc
  • 61958-1805 Harvoni Oral Pellet by Gilead Sciences, Inc

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.