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NDC 61958-2101 Odefsey

Emtricitabine,Rilpivirine Hydrochloride,And 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 61958-2101?
  5. Odefsey 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:
61958-2101
Proprietary Name:
Odefsey
Non-Proprietary Name: [1]
Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide
Substance Name: [2]
Emtricitabine; Rilpivirine Hydrochloride; 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:
    ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5
    FDA Application Number: [6]
    NDA208351
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-01-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    GRAY (C48324)
    Shape:
    OVAL (C48345)
    Size(s):
    15 MM
    Imprint(s):
    GSI;255
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 61958-2101?

    The NDC code 61958-2101 is assigned by the FDA to the product Odefsey which is a human prescription drug product labeled by Gilead Sciences, Inc.. The generic name of Odefsey is emtricitabine, rilpivirine hydrochloride, and 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 61958-2101-1 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 Odefsey?

    This product contains 3 different medications: emtricitabine, rilpivirine, and tenofovir alafenamide. It 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. Emtricitabine and tenofovir alafenamide belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Rilpivirine belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine/rilpivirine/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 Odefsey 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.
    • 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.
    • RILPIVIRINE HYDROCHLORIDE 25 mg/1 - A diarylpyrimidine derivative and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 that is used in the treatment of HIV INFECTIONS. It is also used in combination with other ANTI-HIV AGENTS, since ANTIVIRAL DRUG RESISTANCE emerges rapidly when it is used alone.
    • TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1

    Which are Odefsey UNII Codes?

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

    Which are Odefsey 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 Odefsey?

    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: 1741733 - emtricitabine 200 MG / rilpivirine 25 MG / tenofovir alafenamide 25 MG Oral Tablet
    • RxCUI: 1741733 - emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine HCl 27.5 MG) / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral Tablet
    • RxCUI: 1741739 - ODEFSEY 200 MG / 25 MG/ 25 MG Oral Tablet
    • RxCUI: 1741739 - emtricitabine 200 MG / rilpivirine 25 MG / tenofovir alafenamide 25 MG Oral Tablet [Odefsey]
    • RxCUI: 1741739 - Odefsey (emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine HCl 27.5 MG) / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG)) Oral Tablet

    Which are the Pharmacologic Classes for Odefsey?

    * Please review the disclaimer below.

    Patient Education

    Emtricitabine, Rilpivirine, and Tenofovir


    The combination of emtricitabine, rilpivirine, and tenofovir is used to treat HIV in adults and children who weigh at least 77 pounds (35 kilograms). Emtricitabine, rilpivirine, and tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although emtricitabine, rilpivirine, 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 getting or transmitting the HIV virus 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".