vosevi

Generic: sofosbuvir, velpatasvir, and voxilaprevir

Labeler: gilead sciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vosevi
Generic Name sofosbuvir, velpatasvir, and voxilaprevir
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sofosbuvir 400 mg/1, velpatasvir 100 mg/1, voxilaprevir 100 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-2401
Product ID 61958-2401_6ce7dd60-defa-4530-bff3-de03885e318a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209195
Listing Expiration 2026-12-31
Marketing Start 2017-07-18

Pharmacologic Class

Established (EPC)
hepatitis c virus nucleotide analog ns5b polymerase inhibitor [epc] hepatitis c virus ns5a inhibitor [epc] hepatitis c virus ns3/4a protease inhibitor [epc]
Mechanism of Action
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] hcv ns3/4a protease inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619582401
Hyphenated Format 61958-2401

Supplemental Identifiers

RxCUI
1939329 1939335
UNII
WJ6CA3ZU8B KCU0C7RS7Z 0570F37359
NUI
N0000191493 N0000191258 N0000191256 N0000190113 N0000185503 N0000190107 N0000190108 N0000190109 N0000182639 N0000182638

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vosevi (source: ndc)
Generic Name sofosbuvir, velpatasvir, and voxilaprevir (source: ndc)
Application Number NDA209195 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1)
source: ndc

Packages (1)

Ingredients (3)

sofosbuvir (400 mg/1) velpatasvir (100 mg/1) voxilaprevir (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6ce7dd60-defa-4530-bff3-de03885e318a", "openfda": {"nui": ["N0000191493", "N0000191258", "N0000191256", "N0000190113", "N0000185503", "N0000190107", "N0000190108", "N0000190109", "N0000182639", "N0000182638"], "unii": ["WJ6CA3ZU8B", "KCU0C7RS7Z", "0570F37359"], "rxcui": ["1939329", "1939335"], "spl_set_id": ["17ffc094-8ca7-45d2-80d8-fd043bc9a221"], "pharm_class_epc": ["Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]", "Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus NS3/4A Protease 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]", "HCV NS3/4A Protease 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 (61958-2401-1)", "package_ndc": "61958-2401-1", "marketing_start_date": "20170718"}], "brand_name": "Vosevi", "product_id": "61958-2401_6ce7dd60-defa-4530-bff3-de03885e318a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "HCV NS3/4A Protease Inhibitors [MoA]", "Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]", "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 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]"], "product_ndc": "61958-2401", "generic_name": "SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vosevi", "active_ingredients": [{"name": "SOFOSBUVIR", "strength": "400 mg/1"}, {"name": "VELPATASVIR", "strength": "100 mg/1"}, {"name": "VOXILAPREVIR", "strength": "100 mg/1"}], "application_number": "NDA209195", "marketing_category": "NDA", "marketing_start_date": "20170718", "listing_expiration_date": "20261231"}