NDC 0409-6562 Testosterone Cypionate

Injection, Solution Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0409-6562
Proprietary Name:
Testosterone Cypionate
Non-Proprietary Name: [1]
Testosterone Cypionate
Substance Name: [2]
Testosterone Cypionate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Intramuscular - Administration within a muscle.
  • Labeler Name: [5]
    Labeler Code:
    0409
    FDA Application Number: [6]
    ANDA085635
    DEA Schedule: [7]
    Schedule III (CIII) Substances
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-01-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 0409-6562?

    The NDC code 0409-6562 is assigned by the FDA to the product Testosterone Cypionate which is a human prescription drug product labeled by Hospira, Inc.. The product's dosage form is injection, solution and is administered via intramuscular form. The product is distributed in 4 packages with assigned NDC codes 0409-6562-01 1 vial in 1 carton / 1 ml in 1 vial, 0409-6562-02 1 vial in 1 carton / 1 ml in 1 vial, 0409-6562-20 1 vial in 1 carton / 10 ml in 1 vial, 0409-6562-22 1 vial in 1 carton / 10 ml in 1 vial. 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 Testosterone Cypionate?

    This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.

    What are Testosterone Cypionate 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 Testosterone Cypionate UNII Codes?

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

    Which are Testosterone Cypionate 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 Testosterone Cypionate?

    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: 2047882 - testosterone cypionate 200 MG in 1 ML Injection
    • RxCUI: 2047882 - 1 ML testosterone cypionate 200 MG/ML Injection
    • RxCUI: 2047882 - testosterone cypionate 200 MG per 1 ML Injection
    • RxCUI: 835829 - testosterone cypionate 100 MG/ML Injectable Solution
    • RxCUI: 835829 - testosterone cypionate 1000 MG per 10 ML Injectable Solution

    Which are the Pharmacologic Classes for Testosterone Cypionate?

    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 Injection


    Testosterone cypionate (Depo-Testosterone), testosterone enanthate (Xyosted, available generically), testosterone undecanoate (Aveed), and testosterone pellet (Testopel) are forms of testosterone injection used to treat symptoms of low testosterone in 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 lab tests to check your testosterone levels to see if they are low before you begin to use testosterone injection. Testosterone enanthate (available generically) and testosterone pellet (Testopel) are also used to stimulate puberty in males with delayed puberty. Testosterone enanthate (available generically) injection may be used in certain women with a type of breast cancer called mammary cancer that has spread to other parts of the body. 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 injection works by supplying synthetic testosterone to replace the testosterone that is normally produced naturally in the body. When used to treat breast cancer, testosterone works by stopping the release of estrogen.
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    * 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.

    [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".