Vemlidy Tablet
NDC 61958-2301

View dosage, usage, ingredients, routes, and UNII mappings.
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

Vemlidy (tenofovir alafenamide) is a NDA-approved product labeled by Gilead Sciences, Inc.. Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It is supplied as a yellow tablet for oral administration. This product entry covers the primary NDC 61958-2301 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
11-10-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

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

Code Structure Chart

Product Details

What is NDC 61958-2301?

The NDC code 61958-2301 is assigned by the FDA to the product Vemlidy. It is commonly known by its generic name, tenofovir alafenamide. This pharmaceutical product is labeled by Gilead Sciences, Inc. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 61958-2301-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated 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 the Inactive Ingredients associated 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 this product?

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 of this product?

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.

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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.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".