72626-2701 : Sofosbuvir and Velpatasvir Oral Tablet, Film Coated

Labeler: Asegua Therapeutics LLC
Product Type: Human Prescription Drug
Drug Name:  Sofosbuvir and Velpatasvir
Dosage Form: Oral Tablet, Film Coated
Application #: NDA208341
Rev. Date: 


Markings: ASE;9761
Shapes:  Diamond (4 sides)
Colors:  Pink
Size (mm): 20
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:

  • 72626-2701-1: 2 BLISTER PACK IN 1 CARTON (72626‑2701‑1) > 14 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Velpatasvir
  • Sofosbuvir

Dosage Strength:

  • 100 mg
  • 400 mg

Inactive Ingredients:

  • Alcohol
  • Copovidone K25-31
  • Microcrystalline Cellulose
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Water
  • Titanium Dioxide
  • Polyethylene Glycol 3350
  • Talc
  • Ferric Oxide Red
  • Polyvinyl Alcohol, Unspecified /

Pharmaceutical Classes:

  • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
  • Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]
  • Hepatitis C Virus NS5A Inhibitor [EPC]
  • Breast Cancer Resistance Protein Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]
  • RNA Replicase Inhibitors [MoA]
  • Nucleoside Analog [EXT]


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