colchicine

FDA Drug Profile — colchicine, Colchicine

colchicine is listed in the FDA National Drug Code directory with 13 NDC codes, marketed under brand names including colchicine, Colchicine. Available dosage forms: tablet, tablet, film coated.

Drug Details

Generic Name
colchicine
Brand Names
colchicine, Colchicine
Application Number
ANDA211250
Sponsor
ST. MARY'S MEDICAL PARK PHARMACY
NDC Codes
13
Dosage Forms
TABLET, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
COLCHICINE

Indications and Usage

1 INDICATIONS AND USAGE Colchicine tablets, USP are an alkaloid indicated for: Prophylaxis and treatment of gout flares in adults (1.1) . Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2) . 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. Prophylaxis of Gout Flares : Colchicine tablets are indicated for prophylaxis of gout flares. Treatment of Gout Flares : Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).