NDC 72626-2701

Sofosbuvir and Velpatasvir

Velpatasvir And Sofosbuvir

Sofosbuvir and Velpatasvir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Asegua Therapeutics Llc. The primary component is Velpatasvir; Sofosbuvir.

• Product ID: 72626-2701_3176f9af-1cbb-4c22-a518-75ef434e218b
• NDC: 72626-2701
• Product Type: Human Prescription Drug
• Proprietary Name: Sofosbuvir and Velpatasvir
• Generic Name: Velpatasvir And Sofosbuvir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-14
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA208341
• Labeler Name: Asegua Therapeutics LLC
• Substance Name: VELPATASVIR; SOFOSBUVIR
• Active Ingredient Strength: 100 mg/1; mg/1
• Pharm 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 72626-2701-1

2 BLISTER PACK in 1 CARTON (72626-2701-1) > 14 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2018-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72626-2701-1 [72626270101]

Sofosbuvir and Velpatasvir TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA208341
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-14

Drug Details

Active Ingredients

Ingredient	Strength
VELPATASVIR	100 mg/1

OpenFDA Data

• SPL SET ID: d0c1a945-4440-4b5c-81aa-693ed3db597c
• Manufacturer:
  • Asegua Therapeutics LLC
• UNII:
  • WJ6CA3ZU8B
  • KCU0C7RS7Z
• RxNorm Concept Unique ID - RxCUI:
  • 1799212

Pharmacological Class

• 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]

NDC Crossover Matching brand name "Sofosbuvir and Velpatasvir" or generic name "Velpatasvir And Sofosbuvir"

NDC	Brand Name	Generic Name
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir
61958-2201	Epclusa	Velpatasvir and Sofosbuvir
61958-2203	Epclusa	Velpatasvir and Sofosbuvir
61958-2204	Epclusa	Velpatasvir and Sofosbuvir
61958-2205	Epclusa	Velpatasvir and Sofosbuvir