Male Balance

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)

Energique,inc.
Human Otc Drug
NDC 44911-0126

Male Balance also known as 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) is a human otc drug labeled by 'Energique,inc.'. National Drug Code (NDC) number for Male Balance is 44911-0126. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Male Balance drug includes Avena Sativa Flowering Top - 6 [hp_X]/mL Chaste Tree - 12 [hp_X]/mL Epimedium Grandiflorum Top - 30 [hp_C]/mL Ginkgo - 12 [hp_X]/mL Lycopodium Clavatum Spore - 12 [hp_X]/mL Pork Liver - 6 [hp_X]/mL Serotonin Hydrochloride - 30 [hp_C]/mL Somatropin - 26 [hp_X]/mL Spermidine - 12 [hp_X]/mL Spermine - 12 [hp_X]/mL and more. The currest status of Male Balance drug is Active.

Drug Information:

Drug NDC:	44911-0126
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Male Balance
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	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)
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Energique,inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	AVENA SATIVA FLOWERING TOP - 6 [hp_X]/mL CHASTE TREE - 12 [hp_X]/mL EPIMEDIUM GRANDIFLORUM TOP - 30 [hp_C]/mL GINKGO - 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL PORK LIVER - 6 [hp_X]/mL SEROTONIN HYDROCHLORIDE - 30 [hp_C]/mL SOMATROPIN - 26 [hp_X]/mL SPERMIDINE - 12 [hp_X]/mL SPERMINE - 12 [hp_X]/mL Load more... SUS SCROFA HYPOTHALAMUS - 12 [hp_X]/mL SUS SCROFA TESTICLE - 6 [hp_X]/mL TESTOSTERONE - 6 [hp_X]/mL TURNERA DIFFUSA LEAFY TWIG - 12 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	15 Sep, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	30 Jan, 2025
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.
Listing Expiration Date:	23 Dec, 2025
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Energique,Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175606 M0028842 N0000175824 N0000000146 M0001109
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	MA9CQJ3F7F 433OSF3U8A 137PC46F89 19FUJ2C58T C88X29Y479 6EC706HI7F GKN429M9VS NQX9KB6PCL U87FK77H25 2FZ7Y3VOQX Load more... N6R0856Z79 KM02613O28 3XMK78S47O RQ2CFA7WWJ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Androgen Receptor Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Recombinant Human Growth Hormone [EPC] Androgen [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Human Growth Hormone [CS] Androstanes [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Androgen Receptor Agonists [MoA] Androgen [EPC] Androstanes [CS] Human Growth Hormone [CS] Recombinant Human Growth Hormone [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
DEA Schedule:	CIII
This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
44911-0126-1	30 mL in 1 BOTTLE, SPRAY (44911-0126-1)	15 Sep, 2014	30 Jan, 2025	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Male Balance

Avena Sativa & more..

Liquid
Energique,Inc.
NDC: 44911-0126

Purpose:

Indications: for temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Male balance 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) avena sativa flowering top avena sativa flowering top pork liver pork liver sus scrofa testicle sus scrofa testicle testosterone testosterone chaste tree chaste tree turnera diffusa leafy twig turnera diffusa leafy twig ginkgo ginkgo sus scrofa hypothalamus sus scrofa hypothalamus lycopodium clavatum spore lycopodium clavatum spore spermidine spermidine spermine spermine somatropin somatropin epimedium grandiflorum top epimedium grandiflorum top serotonin hydrochloride serotonin anhydrous citric acid glycerin sodium benzoate water

Indications and Usage:

Warnings:

Warnings: if pregnant or breast-feeding , ask a health professional before use. keep out of reach of children . in case of overdose, get medical help or contact a poison control center right away. do not use if tamper evident seal is broken or missing. store in a cool, dry place.

Dosage and Administration:

Directions: two sprays twice daily. hold in mouth for 30 seconds.

Package Label Principal Display Panel:

Package label display energique since 1987 homeopathic remedy male balance 1 fl. oz. (30 ml) male balance

Further Questions:

Questions: dist. by energique, inc. 201 apple blvd woodbine, ia 51579 800-869-8078

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.