NDC 61958-2203

Epclusa

Velpatasvir And Sofosbuvir

Epclusa 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.

• Product ID: 61958-2203_40f3a9f4-caa0-4d29-8080-1815053c6553
• NDC: 61958-2203
• Product Type: Human Prescription Drug
• Proprietary Name: Epclusa
• Generic Name: Velpatasvir And Sofosbuvir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-03-19
• Marketing Category: NDA / NDA
• Application Number: NDA208341
• Labeler Name: Gilead Sciences, Inc.
• Substance Name: SOFOSBUVIR; VELPATASVIR
• Active Ingredient Strength: 200 mg/1; mg/1
• Pharm 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 61958-2203-1

28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2203-1)

• Marketing Start Date: 2020-03-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61958-2203-1 [61958220301]

Epclusa TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208341
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-18

Drug Details

Active Ingredients

Ingredient	Strength
VELPATASVIR	50 mg/1

OpenFDA Data

• SPL SET ID: 7f30631a-ee3b-4cfe-866b-964df3f0a44f
• Manufacturer:
  • Gilead Sciences, Inc.
• UNII:
  • WJ6CA3ZU8B
  • KCU0C7RS7Z
• RxNorm Concept Unique ID - RxCUI:
  • 2288814
  • 1799218
  • 2288816
  • 1799212
• UPC Code:
  • 0361958220118
  • 0361958220316

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 "Epclusa" or generic name "Velpatasvir And Sofosbuvir"

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