Package 61958-2201-1

Brand: epclusa

Generic: velpatasvir and sofosbuvir
NDC Package

Package Facts

Identity

Package NDC 61958-2201-1
Digits Only 6195822011
Product NDC 61958-2201
Description

28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2201-1)

Marketing

Marketing Status
Marketed Since 2016-06-28
Brand epclusa
Generic velpatasvir and sofosbuvir
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4e28b652-df20-450d-9f6e-4cc6e355e223", "openfda": {"nui": ["N0000191493", "N0000191258", "N0000191256", "N0000190113", "N0000185503", "N0000190107", "N0000190108", "N0000190109"], "unii": ["WJ6CA3ZU8B", "KCU0C7RS7Z"], "rxcui": ["1799212", "1799218", "2288814", "2288816", "2584196", "2584199", "2584200", "2584201"], "spl_set_id": ["7f30631a-ee3b-4cfe-866b-964df3f0a44f"], "pharm_class_epc": ["Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]", "Hepatitis C Virus NS5A Inhibitor [EPC]"], "pharm_class_moa": ["RNA Replicase Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2201-1)", "package_ndc": "61958-2201-1", "marketing_start_date": "20160628"}], "brand_name": "Epclusa", "product_id": "61958-2201_4e28b652-df20-450d-9f6e-4cc6e355e223", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "61958-2201", "generic_name": "Velpatasvir and Sofosbuvir", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Epclusa", "active_ingredients": [{"name": "SOFOSBUVIR", "strength": "400 mg/1"}, {"name": "VELPATASVIR", "strength": "100 mg/1"}], "application_number": "NDA208341", "marketing_category": "NDA", "marketing_start_date": "20160628", "listing_expiration_date": "20261231"}