Genvoya Tablet
NDC 61958-1901

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 61958-1901?
  5. Genvoya 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

Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) is a NDA-approved product labeled by Gilead Sciences, Inc.. This product is used to help control HIV infection. It is supplied as a green tablet for oral administration. This product entry covers the primary NDC 61958-1901 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
61958-1901
Proprietary Name:
Genvoya
Non-Proprietary Name: [1]
Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide
Substance Name: [2]
Cobicistat; Elvitegravir; Emtricitabine; 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:
34784acf-15ed-4715-b504-eb30430518e9
FDA Application Number: [6]
NDA207561
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-05-2015
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
GREEN (C48329)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
GSI;510
Score:
1

Code Structure Chart

Product Details

What is NDC 61958-1901?

The NDC code 61958-1901 is assigned by the FDA to the product Genvoya. It is commonly known by its generic name, elvitegravir, cobicistat, emtricitabine, and 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: 61958-1901-1. 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?

This product is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product contains 4 different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Elvitegravir is known as an integrase inhibitor. Cobicistat helps elvitegravir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor; both kinds of drugs are often called NRTIs. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

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.
  • COBICISTAT 150 mg/1 - A carbamate and thiazole derivative that functions as a CYTOCHROME P450 CYP3A INHIBITOR to enhance the concentration of ANTI-HIV AGENTS, with which it is used in combination, for the treatment of HIV INFECTIONS.
  • ELVITEGRAVIR 150 mg/1 - an HIV-1 integrase inhibitor
  • EMTRICITABINE 200 mg/1 - A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.
  • TENOFOVIR ALAFENAMIDE FUMARATE 10 mg/1

Which are the associated UNII Codes?

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

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: 1721613 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet
  • RxCUI: 1721613 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG (as tenofovir alafenamide fumarate 11.2 MG) Oral Tablet
  • RxCUI: 1721619 - Genvoya 150 MG / 150 MG / 200 MG / 10 MG Oral Tablet
  • RxCUI: 1721619 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet [Genvoya]
  • RxCUI: 1721619 - Genvoya (cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG (as tenofovir alafenamide fumarate 11.2 MG)) 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.

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

Patient Education

Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir


The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir (Genvoya, Stribilid) is used to treat human immunodeficiency virus (HIV) infection in adults and children who have not been treated with other HIV medications or to replace current medication therapy in certain people already taking HIV medications. The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir is in a class of medications called antivirals. Elvitegravir, emtricitabine, and tenofovir work by decreasing the amount of HIV in the blood. Cobicistat helps to keep elvitegravir in the body longer so that the medication will have a greater effect. Although the combination of elvitegravir, cobicistat, emtricitabine and tenofovir will not cure HIV, these medications 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.
[Learn More]


HIV Medicines


What is HIV?

HIV stands for human immunodeficiency virus. It harms your immune system by destroying CD4 cells. These are a type of white blood cells that fight infection. The loss of these cells makes it hard for your body to fight off infections and certain HIV-related cancers.

Without treatment, HIV can gradually destroy the immune system and advance to AIDS. AIDS stands for acquired immunodeficiency syndrome. It is the final stage of infection with HIV. Not everyone with HIV develops AIDS.

What is antiretroviral therapy (ART)?

The treatment of HIV with medicines is called antiretroviral therapy (ART). It involves taking a combination of medicines every day. ART is recommended for everyone who has HIV. The medicines do not cure HIV infection, but help people with HIV live longer, healthier lives. They also reduce the risk of spreading the virus to others.

How do HIV medicines work?

HIV medicines reduce the amount of HIV (viral load) in your body, which helps by:

  • Giving your immune system a chance to recover. Even though there is still some HIV in your body, your immune system should be strong enough to fight off infections and certain HIV-related cancers.
  • Reducing the risk that you will spread HIV to others.

What are the types of HIV medicines?

There are many different types (called classes) of HIV medicines. Some work by blocking or changing enzymes that HIV needs to make copies of itself. This prevents HIV from copying itself, which reduces the amount of HIV in the body. Several types of medicines do this:

  • Nucleoside reverse transcriptase inhibitors (NRTIs) block an enzyme called reverse transcriptase
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs) bind to and later change reverse transcriptase
  • Integrase inhibitors, also called integrase strand transfer inhibitors (INSTIs), block an enzyme called integrase
  • Protease inhibitors (PIs) block an enzyme called protease

Some types of HIV medicines interfere with HIV's ability to infect CD4 immune system cells:

  • Fusion inhibitors block HIV from entering the cells
  • CCR5 antagonists and post-attachment inhibitors block different molecules on the CD4 cells. To infect a cell, HIV has to bind to two types of molecules on the cell's surface. Blocking either of these molecules prevents HIV from entering the cells.
  • Attachment inhibitors bind to a specific protein on the outer surface of HIV. This prevents HIV from entering the cell.

Pharmacokinetic enhancers are another type of medicine. They are sometimes taken along with certain other HIV medicines. Pharmacokinetic enhancers increase the effectiveness of the other medicine. They work by slowing the breakdown of the other medicine. This allows that medicine to stay in the body longer at a higher concentration.

There are also multidrug combinations, which include a combination of two or more different types of HIV medicines.

When do I need to start taking HIV medicines?

It's important to start taking HIV medicines as soon as possible after your diagnosis, especially if you:

  • Are pregnant
  • Have AIDS
  • Have certain HIV-related illnesses and infections
  • Have an early HIV infection (the first 6 months after infection with HIV)

What else do I need to know about taking HIV medicines?

You and your health care provider will work together to come up with a personal treatment plan. This plan will be based on many factors, including:

  • The possible side effects of HIV medicines
  • Potential drug interactions with any other medicines you take
  • How many medicines you will need to take every day
  • Any other health problems you may have

It's important to take your medicines every day, according to the instructions from your provider. If you miss doses or don't follow a regular schedule, your treatment may not work, and the HIV virus may become resistant to the medicines.

HIV medicines can cause side effects. Most of these side effects are manageable, but a few can be serious. Tell your provider about any side effects that you are having. Don't stop taking your medicine without first talking to your provider. There may be steps you can take to help manage the side effects. In some cases, your provider may decide to change your medicines.

What are HIV PrEP and PEP medicines?

HIV medicines are not just used for treatment. Some people take them to prevent HIV. PrEP (pre-exposure prophylaxis) is for people who don't already have HIV but are at very high risk of getting it. PEP (post-exposure prophylaxis) is for people who have possibly been exposed to HIV.

NIH: Office of AIDS Research


[Learn More]


* 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".