1. Labeler Index
  2. Abbvie Inc.
  3. NDC Product Code: 0051-8462 Androgel

NDC 0051-8462 Androgel

Testosterone Gel Transdermal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0051-8462?
    4. Androgel Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code:
0051-8462
Proprietary Name:
Androgel
Non-Proprietary Name: [1]
Testosterone
Substance Name: [2]
Testosterone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Labeler Name: [5]
    Abbvie Inc.
    Labeler Code:
    0051
    Product Label ID:
    8677ba5b-8374-46cb-854c-403972e9ddf3
    FDA Application Number: [6]
    NDA022309
    DEA Schedule: [7]
    Schedule III (CIII) Substances
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-29-2011
    End Marketing Date: [10]
    05-01-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0051-8462-33

    Package Description: 1 BOTTLE, PUMP in 1 CARTON / 88 g in 1 BOTTLE, PUMP

    Price per Unit: $7.93572 per GM

    Product Details

    What is NDC 0051-8462?

    The NDC code 0051-8462 is assigned by the FDA to the product Androgel which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Androgel is testosterone. The product's dosage form is gel and is administered via transdermal form. The product is distributed in a single package with assigned NDC code 0051-8462-33 1 bottle, pump in 1 carton / 88 g in 1 bottle, pump. 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 Androgel?

    This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (for example, due to hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. This drug should not be used by women.

    What are Androgel 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.
    • TESTOSTERONE 16.2 mg/g - A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.

    Which are Androgel UNII Codes?

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

    Which are Androgel 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 Androgel?

    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: 1597075 - AndroGel 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT
    • RxCUI: 1597075 - 60 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel [Androgel]
    • RxCUI: 1597076 - testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT
    • RxCUI: 1597076 - 60 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel
    • RxCUI: 1597120 - testosterone 1.62 % (20.25MG / 1.25GM) Transdermal Gel

    Which are the Pharmacologic Classes for Androgel?

    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.

    Patient Education

    Testosterone Topical


    Testosterone topical is used to treat the symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain tests to check your testosterone levels to see if they are low before you begin to use testosterone topical. Testosterone should not be used to treat the symptoms of low testosterone in men who have low testosterone due to aging ('age related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone topical works by replacing the testosterone that is normally produced by the body.
    [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.

    [7] What is the Drug Enforcement Administration (DEA) CIII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".