NDC 69761-420 Testosterone / Cholesterol

Testosterone / Cholesterol

NDC Product Code 69761-420

NDC CODE: 69761-420

Proprietary Name: Testosterone / Cholesterol 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 / Cholesterol 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

NDC 69761-420-06

Package Description: 6 PELLET, IMPLANTABLE in 1 PACKAGE

NDC 69761-420-12

Package Description: 12 PELLET, IMPLANTABLE in 1 PACKAGE

NDC 69761-420-30

Package Description: 30 PELLET, IMPLANTABLE in 1 PACKAGE

NDC Product Information

Testosterone / Cholesterol with NDC 69761-420 is a a human prescription drug product labeled by Qualgen Llc. The generic name of Testosterone / Cholesterol is testosterone / cholesterol. The product's dosage form is pellet, implantable and is administered via parenteral form.

Labeler Name: Qualgen Llc

Dosage Form: Pellet, Implantable - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time.

Product Type: Human Prescription 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 / Cholesterol 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 200 mg/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.

  • CHOLESTEROL (UNII: 97C5T2UQ7J)

Administration Route(s)

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

  • Parenteral - Administration by injection, infusion, or implantation.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Androgen - [EPC] (Established Pharmacologic Class)
  • Androgen Receptor Agonists - [MoA] (Mechanism of Action)
  • Androstanes - [CS]

Product Labeler Information

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

Labeler Name: Qualgen Llc
Labeler Code: 69761
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-20-2020 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: 12-31-2021 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’.

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Testosterone / Cholesterol Product Label Images

Testosterone / Cholesterol 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

Description

Estradiol 12mg pellet

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