61958-2201 : Epclusa Oral Tablet, Film Coated


NDC: 61958-2201
Labeler: Gilead Sciences, Inc.
Product Type: Human Prescription Drug
Drug Name:  Epclusa
Dosage Form: Oral Tablet, Film Coated
Application #: NDA208341
Rev. Date: 


Appearance:


Markings: GSI;7916
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:

  • 61958-2201-1: 28 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (61958‑2201‑1)

Active Ingredients:

  • Sofosbuvir
  • Velpatasvir

Dosage Strength:

  • 400 mg
  • 100 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:

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

Related Products:

Based on records with the same trade name.
  • 61958-2203 Epclusa Oral Tablet, Film Coated by Gilead Sciences, Inc.
  • 61958-2204 Epclusa Oral Pellet by Gilead Sciences, Inc.
  • 61958-2205 Epclusa Oral Pellet by Gilead Sciences, Inc.

NDC QR Code

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NDC 61958-2201 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.