NDC 71589-011 Testosterone

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
71589-011
Proprietary Name:
Testosterone
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aleor Dermaceuticals Limited
Labeler Code:
71589
Start Marketing Date: [9]
03-12-2021
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 71589-011-88

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

Product Details

What is NDC 71589-011?

The NDC code 71589-011 is assigned by the FDA to the product Testosterone which is product labeled by Aleor Dermaceuticals Limited. The product's dosage form is . The product is distributed in a single package with assigned NDC code 71589-011-88 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 Testosterone?

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.

Which are Testosterone UNII Codes?

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

Which are Testosterone 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?

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: 1597076 - testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT
  • RxCUI: 1597076 - 60 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel

* 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.
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* Please review the disclaimer below.

Product Footnotes

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

[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".