epclusa
Generic: velpatasvir and sofosbuvir
Labeler: gilead sciences, inc.Drug Facts
Product Profile
Brand Name
epclusa
Generic Name
velpatasvir and sofosbuvir
Labeler
gilead sciences, inc.
Dosage Form
PELLET
Routes
Active Ingredients
sofosbuvir 200 mg/1, velpatasvir 50 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
61958-2204
Product ID
61958-2204_4e28b652-df20-450d-9f6e-4cc6e355e223
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA214187
Listing Expiration
2026-12-31
Marketing Start
2021-06-10
Pharmacologic Class
Established (EPC)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
619582204
Hyphenated Format
61958-2204
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
epclusa (source: ndc)
Generic Name
velpatasvir and sofosbuvir (source: ndc)
Application Number
NDA214187 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 200 mg/1
- 50 mg/1
Packaging
- 28 PACKET in 1 CARTON (61958-2204-1) / 1 PELLET in 1 PACKET
Packages (1)
Ingredients (2)
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 PACKET in 1 CARTON (61958-2204-1) / 1 PELLET in 1 PACKET", "package_ndc": "61958-2204-1", "marketing_start_date": "20210610"}], "brand_name": "Epclusa", "product_id": "61958-2204_4e28b652-df20-450d-9f6e-4cc6e355e223", "dosage_form": "PELLET", "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": "61958-2204", "generic_name": "Velpatasvir and Sofosbuvir", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Epclusa", "active_ingredients": [{"name": "SOFOSBUVIR", "strength": "200 mg/1"}, {"name": "VELPATASVIR", "strength": "50 mg/1"}], "application_number": "NDA214187", "marketing_category": "NDA", "marketing_start_date": "20210610", "listing_expiration_date": "20261231"}