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  4. NDC Product Code: 62064-241 Egrifta Sv

NDC 62064-241 Egrifta Sv

Tesamorelin Kit Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 62064-241?
  5. Egrifta Sv Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
62064-241
Proprietary Name:
Egrifta Sv
Non-Proprietary Name: [1]
Tesamorelin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Labeler Name: [5]
    Theratechnologies Inc.
    Labeler Code:
    62064
    Product Label ID:
    3d783378-b02d-4f19-99dd-0fc91a042224
    FDA Application Number: [6]
    BLA022505
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    11-04-2019
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE )

    Code Structure Chart

    Product Details

    What is NDC 62064-241?

    The NDC code 62064-241 is assigned by the FDA to the product Egrifta Sv which is a human prescription drug product labeled by Theratechnologies Inc.. The generic name of Egrifta Sv is tesamorelin. The product's dosage form is kit and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 62064-241-30 1 kit in 1 box * .5 ml in 1 vial * 30 bottle in 1 tray / 10 ml in 1 bottle. 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 Egrifta Sv?

    EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.Limitations of Use:Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect.There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.

    Which are Egrifta Sv UNII Codes?

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

    Which are Egrifta Sv 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 Egrifta Sv?

    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:

    * Please review the disclaimer below.

    Patient Education

    Tesamorelin Injection


    Tesamorelin injection is used to decrease the amount of extra fat in the stomach area in adults with human immunodeficiency virus (HIV) who have lipodystrophy (increased body fat in certain areas of the body). Tesamorelin injection is not used to help with weight loss. Tesamorelin injection is in a class of medications called human growth hormone-releasing factor (GRF) analogs. It works by increasing the production of a certain natural substance that can decrease the amount of body fat.
    [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.

    [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".