Raltegravir

FDA Drug Profile — Raltegravir

Raltegravir is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Raltegravir. Available dosage forms: powder, tablet, film coated.

Drug Details

Generic Name
Raltegravir
Brand Names
Raltegravir
Application Number
ANDA203540
Sponsor
Siegfried Evionnaz SA
NDC Codes
3
Dosage Forms
POWDER, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
RALTEGRAVIR POTASSIUM

Indications and Usage

1 INDICATIONS AND USAGE Adult Patients: ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ( 1 ). Pediatric Patients: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg ( 1 ). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg ( 1 ). Adult Patients: ISENTRESS ® and ISENTRESS ® HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. Pediatric Patients: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg. ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg.