NDC 44117-0002 Testosterone

Testosterone,

NDC Product Code 44117-0002

NDC CODE: 44117-0002

Proprietary Name: Testosterone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Testosterone, 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., 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.

NDC Code Structure

  • 44117 - Zoe Processing

NDC 44117-0002-1

Package Description: 50 TABLET in 1 BOTTLE

NDC Product Information

Testosterone with NDC 44117-0002 is a a human over the counter drug product labeled by Zoe Processing. The generic name of Testosterone is testosterone, . The product's dosage form is tablet and is administered via oral form.

Labeler Name: Zoe Processing

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

DEA Schedule: Schedule III (CIII) Substances What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.

Testosterone Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TESTOSTERONE 30 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Zoe Processing
Labeler Code: 44117
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 04-29-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Testosterone Product Label Images

Testosterone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient:

Testosterone 30X.

Indications:

May help increase lean muscle mass and sexual libido, also may help decrease symptoms of fatigue.

May help increase lean muscle mass and sexual libido, also may help decrease symptoms of fatigue.

Warnings:

Not intended for persons under the age of 18.  If pregnant or breast-feeding, do not use.Consult a health professional prior to use if you have any pre-existing medical conditions or take any prescription medications.Do not consume with any caffeine or stimulants.  Improper use will not improve results and is potentially hazardous to a person's health.Use only as directed.Keep out of reach of children.  In case of overdose, get medical help or contact a Poision Control Center right away.Do not use if tamper evident seal is broken or missing.

Keep Out Of Reach Of Children:

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults take 1-2 tablets daily.  Read warnings and use only as directed.

Inactive Ingredients:

Microcrystaline cellulose, Magnesium stearate, Croscarmellose sodium, Silicon dioxide, Stearic acid.

Questions:

Developed and manufactured for:Zoe ProcessingP.O. Box 487Avon, OH 44011WWW.TESTOSTERONERX.COMTo report a serious adverse event or obtain product information, please cal 1-866-607-2768.

Package Label Display:

Testosterone TabletsHomeopathic50 tablets

* Please review the disclaimer below.