ANDROGEL

This brand name is authorized in Austria, Brazil, Canada, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Netherlands, Romania, Singapore, United States, South Africa

Active ingredients

The drug ANDROGEL contains one active pharmaceutical ingredient (API):

1 Testosterone UNII 3XMK78S47O - TESTOSTERONE

Testosterone, secreted by the testes and its major metabolite dihydrotestosterone (DHT), is responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion. Read about Testosterone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ANDROGEL 1% Gel	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
G03BA03	Testosterone	G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03B Androgens → G03BA 3-oxoandrosten (4) derivatives
Discover more medicines within G03BA03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 542214120000405, 542214120000505
Country: CA	Health Products and Food Branch	Identifier(s): 02245345, 02245346, 02249499
Country: EE	Ravimiamet	Identifier(s): 1195253
Country: FR	Base de données publique des médicaments	Identifier(s): 64205548, 68097237
Country: HK	Department of Health Drug Office	Identifier(s): 57973, 57974
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-864783232
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4677
Country: NL	Z-Index G-Standaard	Identifier(s): 14943581
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 131865, 74225
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W62752001, W62752002, W62752003, W62752004
Country: SG	Health Sciences Authority	Identifier(s): 13161P, 13162P
Country: US	FDA, National Drug Code	Identifier(s): 0051-8425, 0051-8450, 0051-8462
Country: ZA	Health Products Regulatory Authority	Identifier(s): A40/21.7/0260