61958-2203 : Epclusa Oral Tablet, Film Coated


NDC61958-2203
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;S;V
Shapes:  Oval
Colors:  Pink
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:

  • 61958-2203-1: 28 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (61958‑2203‑1)

Active Ingredients:

  • Velpatasvir
  • Sofosbuvir

Dosage Strength:

  • 50 mg
  • 200 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]

Related Products:

Based on records with the same trade name.
  • 61958-2201 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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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.