sofosbuvir and velpatasvir

Generic: velpatasvir and sofosbuvir

Labeler: asegua therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sofosbuvir and velpatasvir
Generic Name velpatasvir and sofosbuvir
Labeler asegua therapeutics llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sofosbuvir 400 mg/1, velpatasvir 100 mg/1

Manufacturer
Asegua Therapeutics LLC

Identifiers & Regulatory

Product NDC 72626-2701
Product ID 72626-2701_314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA208341
Listing Expiration 2026-12-31
Marketing Start 2018-11-14

Pharmacologic Class

Established (EPC)
hepatitis c virus nucleotide analog ns5b polymerase inhibitor [epc] hepatitis c virus ns5a 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 726262701
Hyphenated Format 72626-2701

Supplemental Identifiers

RxCUI
1799212
UNII
WJ6CA3ZU8B KCU0C7RS7Z
NUI
N0000191493 N0000191258 N0000191256 N0000190113 N0000185503 N0000190107 N0000190108 N0000190109

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 sofosbuvir and velpatasvir (source: ndc)
Generic Name velpatasvir and sofosbuvir (source: ndc)
Application Number NDA208341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (72626-2701-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

72626-2701-1 2 BLISTER PACK in 1 CARTON (72626-2701-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Sofosbuvir and Velpatasvir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d", "openfda": {"nui": ["N0000191493", "N0000191258", "N0000191256", "N0000190113", "N0000185503", "N0000190107", "N0000190108", "N0000190109"], "unii": ["WJ6CA3ZU8B", "KCU0C7RS7Z"], "rxcui": ["1799212"], "spl_set_id": ["d0c1a945-4440-4b5c-81aa-693ed3db597c"], "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": ["Asegua Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (72626-2701-1)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "72626-2701-1", "marketing_start_date": "20181114"}], "brand_name": "Sofosbuvir and Velpatasvir", "product_id": "72626-2701_314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d", "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": "72626-2701", "generic_name": "Velpatasvir and Sofosbuvir", "labeler_name": "Asegua Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sofosbuvir and Velpatasvir", "active_ingredients": [{"name": "SOFOSBUVIR", "strength": "400 mg/1"}, {"name": "VELPATASVIR", "strength": "100 mg/1"}], "application_number": "NDA208341", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20181114", "listing_expiration_date": "20261231"}