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
A-S Medication Solutions
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).