NDC 44911-0126 Male Balance

Avena Sativa,Hepar Suis,Orchitinum (suis),Testosterone,Agnus Castus,Damiana,Ginkgo - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
44911-0126
Proprietary Name:
Male Balance
Non-Proprietary Name: [1]
Avena Sativa, Hepar Suis, Orchitinum (suis), Testosterone, Agnus Castus, Damiana, Ginkgo Biloba, Hypothalamus (suis), Lycopodium Clabatum, Spermidine, Spermine, Human Growth Hormone, Epimedium Grandiflorum, Serotonin (hydrochloride)
Substance Name: [2]
Avena Sativa Flowering Top; Chaste Tree; Epimedium Grandiflorum Top; Ginkgo; Lycopodium Clavatum Spore; Pork Liver; Serotonin Hydrochloride; Somatropin; Spermidine; Spermine; Sus Scrofa Hypothalamus; Sus Scrofa Testicle; Testosterone; Turnera Diffusa Leafy Twig
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Energique,inc.
    Labeler Code:
    44911
    DEA Schedule: [7]
    Schedule III (CIII) Substances
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    09-15-2014
    End Marketing Date: [10]
    01-30-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 44911-0126-1

    Package Description: 30 mL in 1 BOTTLE, SPRAY

    Product Details

    What is NDC 44911-0126?

    The NDC code 44911-0126 is assigned by the FDA to the product Male Balance which is a human over the counter drug product labeled by Energique,inc.. The generic name of Male Balance is avena sativa, hepar suis, orchitinum (suis), testosterone, agnus castus, damiana, ginkgo biloba, hypothalamus (suis), lycopodium clabatum, spermidine, spermine, human growth hormone, epimedium grandiflorum, serotonin (hydrochloride). The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 44911-0126-1 30 ml in 1 bottle, spray . 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 Male Balance?

    For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration. For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

    What are Male Balance 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 Male Balance UNII Codes?

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

    Which are Male Balance 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:

    Which are the Pharmacologic Classes for Male Balance?

    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.

    [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".