Epclusa is a Oral Pellet in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Sofosbuvir; Velpatasvir.
Product ID | 61958-2204_40f3a9f4-caa0-4d29-8080-1815053c6553 |
NDC | 61958-2204 |
Product Type | Human Prescription Drug |
Proprietary Name | Epclusa |
Generic Name | Velpatasvir And Sofosbuvir |
Dosage Form | Pellet |
Route of Administration | ORAL |
Marketing Start Date | 2021-06-10 |
Marketing Category | NDA / |
Application Number | NDA214187 |
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 |
Marketing Start Date | 2021-06-10 |
NDC Exclude Flag | N |
Sample Package? | N |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EPCLUSA 86282353 4911858 Live/Registered |
GILEAD SCIENCES IRELAND UC 2014-05-15 |