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  4. NDC Product Code: 61958-2301 Vemlidy

NDC 61958-2301 Vemlidy

Tenofovir Alafenamide Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 61958-2301?
  5. Vemlidy 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:
61958-2301
Proprietary Name:
Vemlidy
Non-Proprietary Name: [1]
Tenofovir Alafenamide
Substance Name: [2]
Tenofovir Alafenamide Fumarate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Gilead Sciences, Inc.
    Labeler Code:
    61958
    Product Label ID:
    72e6b33c-0351-4070-9172-eeaa186c01d2
    FDA Application Number: [6]
    NDA208464
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    11-10-2016
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    Shape:
    ROUND (C48348)
    Size(s):
    8 MM
    Imprint(s):
    GSI;25
    Score:
    1

    Product Packages

    NDC Code 61958-2301-1

    Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

    Price per Unit: $46.41252 per EA

    Product Details

    What is NDC 61958-2301?

    The NDC code 61958-2301 is assigned by the FDA to the product Vemlidy which is a human prescription drug product labeled by Gilead Sciences, Inc.. The generic name of Vemlidy is tenofovir alafenamide. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 61958-2301-1 30 tablet in 1 bottle, plastic . 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 Vemlidy?

    Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It works by stopping or slowing the growth of the virus. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if tenofovir alafenamide can cure hepatitis B or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

    What are Vemlidy 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.

    Which are Vemlidy UNII Codes?

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

    • TENOFOVIR ALAFENAMIDE FUMARATE (UNII: FWF6Q91TZO)
    • TENOFOVIR ANHYDROUS (UNII: W4HFE001U5) (Active Moiety)

    Which are Vemlidy 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 Vemlidy?

    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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1858261 - tenofovir alafenamide 25 MG Oral Tablet
    • RxCUI: 1858261 - tenofovir alafenamide 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral Tablet
    • RxCUI: 1858267 - Vemlidy 25 MG Oral Tablet
    • RxCUI: 1858267 - tenofovir alafenamide 25 MG Oral Tablet [Vemlidy]
    • RxCUI: 1858267 - Vemlidy 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral Tablet

    Which are the Pharmacologic Classes for Vemlidy?

    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

    Tenofovir disoproxil fumarate/Tenofovir alafenamide


    Tenofovir disoproxil fumarate (DF) (Viread) is used along with other medications to treat HIV infection in adults and children 2 years of age and older weighing 22 pounds (10 kilograms) or more. Tenofovir DF is also used to treat chronic (long term) HBV in adults and children 2 years of age and older weighing 22 pounds (10 kilograms) or more. Tenofovir alafenamide (AF) (Vemlidy) is used to treat chronic (long term) HBV in adults and children 12 years of age and older who have stable liver disease. Tenofovir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and HBV in the blood. Although tenofovir will not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting the HIV virus to other people. Tenofovir will not cure hepatitis B and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Tenofovir may not prevent the spread of hepatitis B to other people.
    [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".