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  4. NDC Product Code: 72626-2701 Sofosbuvir And Velpatasvir

NDC 72626-2701 Sofosbuvir And Velpatasvir

Velpatasvir And Sofosbuvir Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 72626-2701?
  5. Sofosbuvir And Velpatasvir Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
72626-2701
Proprietary Name:
Sofosbuvir And Velpatasvir
Non-Proprietary Name: [1]
Velpatasvir And Sofosbuvir
Substance Name: [2]
Sofosbuvir; Velpatasvir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Asegua Therapeutics Llc
    Labeler Code:
    72626
    Product Label ID:
    d0c1a945-4440-4b5c-81aa-693ed3db597c
    FDA Application Number: [6]
    NDA208341
    Marketing Category: [8]
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date: [9]
    11-14-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    DIAMOND (C48338)
    Size(s):
    20 MM
    Imprint(s):
    ASE;9761
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 72626-2701?

    The NDC code 72626-2701 is assigned by the FDA to the product Sofosbuvir And Velpatasvir which is a human prescription drug product labeled by Asegua Therapeutics Llc. The generic name of Sofosbuvir And Velpatasvir is velpatasvir and sofosbuvir. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 72626-2701-1 2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Sofosbuvir And Velpatasvir?

    Sofosbuvir and velpatasvir tablets are indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2) and Clinical Studies (14)]:without cirrhosis or with compensated cirrhosiswith decompensated cirrhosis for use in combination with ribavirin.

    What are Sofosbuvir And Velpatasvir Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • SOFOSBUVIR 400 mg/1 - A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.
    • VELPATASVIR 100 mg/1

    Which are Sofosbuvir And Velpatasvir UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Sofosbuvir And Velpatasvir Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Sofosbuvir And Velpatasvir?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:

    Which are the Pharmacologic Classes for Sofosbuvir And Velpatasvir?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Sofosbuvir and Velpatasvir


    The combination of sofosbuvir and velpatasvir is used alone or with ribavirin (Copegus, Rebetol, Ribasphere) to treat chronic hepatitis C (an ongoing viral infection that damages the liver) in adults and children 6 years of age and older or who weigh at least 37 lbs (17 kg). Sofosbuvir is in a class of antiviral medications called nucleotide hepatitis C virus (HCV) NS5B polymerase inhibitors. Velpatasvir is in a class of antiviral medications called HCV NS5A replication complex inhibitors. The combination of sofosbuvir and velpatasvir works by stopping the virus that causes hepatitis C from spreading inside the body.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".