ANDROGEL 1% Gel Ref.[10748] Active ingredients: Testosterone

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

AndroGel (testosterone gel) 1% is a clear, colorless hydroalcoholic gel containing testosterone.

The active pharmacologic ingredient in AndroGel 1% is testosterone, an androgen. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one.

The structural formula is:

Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.

Dosage Forms and Strengths

AndroGel (testosterone gel) 1% for topical use is available as follows:

  • A unit dose packet containing 25 mg of testosterone provided in 2.5 g of gel.
  • A unit dose packet containing 50 mg of testosterone provided in 5 g of gel.
How Supplied

AndroGel 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively.

NDC NumberPackage Size
0051-8425-30 30 packets (a unit dose packet containing 25 mg of testosterone provided in 2.5 g of gel)
0051-8450-30 30 packets (a unit dose packet containing 50 mg of testosterone provided in 5 g of gel)

Marketed by: AbbVie Inc., North Chicago, IL 60064, USA

Drugs

Drug Countries
ANDROGEL Austria, Brazil, Canada, Estonia, France, Hong Kong, Ireland, Israel, Netherlands, Romania, Singapore, United States, South Africa

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