NDC 0378-7007
Ketaconazole
Ketaconazole
Ketaconazole is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Ketoconazole.
| Product ID | 0378-7007_d7dc70c0-ca7d-42cc-bf8e-13dd6459ebb7 |
| NDC | 0378-7007 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ketaconazole |
| Generic Name | Ketaconazole |
| Dosage Form | Aerosol, Foam |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2018-12-20 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA021738 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | KETOCONAZOLE |
| Active Ingredient Strength | 20 mg/g |
| Pharm Classes | Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |