NDC 61958-2401

Vosevi

Sofosbuvir, Velpatasvir, And Voxilaprevir

Vosevi 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 Sofosbuvir; Velpatasvir; Voxilaprevir.

• Product ID: 61958-2401_1fb72895-3539-47ce-8b3b-b5170ff167dc
• NDC: 61958-2401
• Product Type: Human Prescription Drug
• Proprietary Name: Vosevi
• Generic Name: Sofosbuvir, Velpatasvir, And Voxilaprevir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-18
• Marketing Category: NDA / NDA
• Application Number: NDA209195
• Labeler Name: Gilead Sciences, Inc.
• Substance Name: SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
• Active Ingredient Strength: 400 mg/1; mg/1; mg/1
• Pharm Classes: Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [EXT],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 NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 61958-2401-1

28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1)

• Marketing Start Date: 2017-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61958-2401-1 [61958240101]

Vosevi TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209195
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-18

Drug Details

Active Ingredients

Ingredient	Strength
SOFOSBUVIR	400 mg/1

OpenFDA Data

• SPL SET ID: 17ffc094-8ca7-45d2-80d8-fd043bc9a221
• Manufacturer:
  • Gilead Sciences, Inc.
• UNII:
  • 0570F37359
  • WJ6CA3ZU8B
  • KCU0C7RS7Z
• RxNorm Concept Unique ID - RxCUI:
  • 1939335
  • 1939329

Pharmacological Class

• Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]
• RNA Replicase Inhibitors [MoA]
• Nucleoside Analog [EXT]
• 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 NS3/4A Protease Inhibitor [EPC]
• HCV NS3/4A Protease Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]