imiquimod

FDA Drug Profile — Imiquimod, Zyclara

imiquimod is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including Imiquimod, Zyclara. Available dosage forms: cream, powder.

Drug Details

Generic Name
imiquimod
Brand Names
Imiquimod, Zyclara
Application Number
NDA022483
Sponsor
Oceanside Pharmacueticals
NDC Codes
6
Dosage Forms
CREAM, POWDER
Routes
TOPICAL
Active Ingredients
IMIQUIMOD

Indications and Usage

1 INDICATIONS AND USAGE Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. ( 1.1 ) Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. ( 1.2 ) 1.1 Actinic Keratosis Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. 1.2 External Genital Warts Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older.