ketoconazole
ketoconazole is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand names including Ketodan, ketoconazole, KETOCONAZOLE. Available dosage forms: aerosol, foam, tablet, cream.
Drug Details
- Generic Name
- ketoconazole
- Brand Names
- Ketodan, ketoconazole, KETOCONAZOLE
- Application Number
- ANDA091550
- Sponsor
- Medimetriks Pharmaceuticals, Inc.
- NDC Codes
- 12
- Dosage Forms
- AEROSOL, FOAM, TABLET, CREAM
- Routes
- TOPICAL, ORAL
- Active Ingredients
- KETOCONAZOLE
Indications and Usage
1 INDICATIONS AND USAGE RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established. RECORLEV is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative ( 1 ) Limitations of Use RECORLEV is not approved for the treatment of fungal infections ( 1 )