posaconazole
posaconazole is listed in the FDA National Drug Code directory with 20 NDC codes, marketed under brand names including posaconazole, POSACONAZOLE, NOXAFIL. Available dosage forms: suspension, tablet, coated, granule, tablet, delayed release, solution.
Drug Details
- Generic Name
- posaconazole
- Brand Names
- posaconazole, POSACONAZOLE, NOXAFIL
- Application Number
- ANDA208773
- Sponsor
- Hikma Pharmaceuticals USA Inc.
- NDC Codes
- 20
- Dosage Forms
- SUSPENSION, TABLET, COATED, GRANULE, TABLET, DELAYED RELEASE, SOLUTION, INJECTION, SOLUTION, POWDER, FOR SUSPENSION
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- POSACONAZOLE
Indications and Usage
1 INDICATIONS AND USAGE Posaconazole delayed-release tablets are an azole antifungal indicated as follows: Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2 ) Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (14.2) ] as follows: Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.