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  4. NDC Product Code: 67979-002 Supprelin LA

NDC 67979-002 Supprelin LA

Histrelin Acetate Implant Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 67979-002?
  4. Supprelin LA Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
67979-002
Proprietary Name:
Supprelin LA
Non-Proprietary Name: [1]
Histrelin Acetate
Substance Name: [2]
Histrelin Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Labeler Name: [5]
    Endo Pharmaceuticals Inc.
    Labeler Code:
    67979
    Product Label ID:
    d8fb000e-3cc9-4803-b71d-2cc597661977
    FDA Application Number: [6]
    NDA022058
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-31-2007
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 67979-002?

    The NDC code 67979-002 is assigned by the FDA to the product Supprelin LA which is a human prescription drug product labeled by Endo Pharmaceuticals Inc.. The generic name of Supprelin LA is histrelin acetate. The product's dosage form is implant and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 67979-002-01 1 vial, glass in 1 carton / 1 implant in 1 vial, glass. 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 Supprelin LA?

    Histrelin is used in men to treat advanced prostate cancer. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Histrelin works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment. Histrelin is also used in children to treat early puberty (central precocious puberty). It helps to slow abnormally fast bone development so that height and growth rate are near normal and to stop or reverse signs of early puberty (such as breast/pubic hair growth in girls, pubic hair growth in boys). Histrelin works by reducing the amount of testosterone in boys and estrogen in girls. This medication is used until the doctor decides it is time for puberty to resume.

    What are Supprelin LA 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 Supprelin LA UNII Codes?

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

    Which are Supprelin LA 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 Supprelin LA?

    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: 1294641 - Supprelin LA 50 MG (65 MCG per 24HR) Subcutaneous Drug Implant
    • RxCUI: 1294641 - histrelin acetate 0.00271 MG/HR Drug Implant [Supprelin]
    • RxCUI: 1294641 - Supprelin 50 MG (65 MCG per 24 HR) Drug Implant
    • RxCUI: 1740437 - histrelin acetate 50 MG (65 MCG per 24HR) Subcutaneous Drug Implant
    • RxCUI: 1740437 - histrelin acetate 0.00271 MG/HR Drug Implant

    Which are the Pharmacologic Classes for Supprelin LA?

    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.

    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".