NDC 69761-312 Testosterone Cypionate

Testosterone Cypionate

NDC Product Code 69761-312

NDC CODE: 69761-312

Proprietary Name: Testosterone Cypionate 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 Cypionate 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 medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.

NDC Code Structure

  • 69761 - Qualgen Llc

NDC 69761-312-11

Package Description: 1 VIAL, GLASS in 1 BOX > 10 mL in 1 VIAL, GLASS

NDC Product Information

Testosterone Cypionate with NDC 69761-312 is a a human prescription drug product labeled by Qualgen Llc. The generic name of Testosterone Cypionate is testosterone cypionate. The product's dosage form is solution and is administered via intramuscular form.

Labeler Name: Qualgen Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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 Cypionate 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 CYPIONATE 200 mg/mL

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.

  • BENZYL BENZOATE (UNII: N863NB338G)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)

Administration Route(s)

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

  • Intramuscular - Administration within a muscle.

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: 01-02-2021 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 Cypionate Product Label Images

Testosterone Cypionate 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

TESTOSTERONE CYPIONATEIM or SQ InjectionContains (per vial):Testosterone Cypionate 2g,Benzyl Benzoate 2mL,Benzyl Alcohol 0.9mL andGrapeseed Oil

* Please review the disclaimer below.