| Product NDC: | 16110-080 |
| Proprietary Name: | Xolegel |
| Non Proprietary Name: | ketoconazole |
| Active Ingredient(s): | 20 mg/g & nbsp; ketoconazole |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | GEL |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16110-080 |
| Labeler Name: | Aqua Pharmaceuticals, LLC. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021946 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20060728 |
| Package NDC: | 16110-080-45 |
| Package Description: | 1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE |
| NDC Code | 16110-080-45 |
| Proprietary Name | Xolegel |
| Package Description | 1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE |
| Product NDC | 16110-080 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ketoconazole |
| Dosage Form Name | GEL |
| Route Name | TOPICAL |
| Start Marketing Date | 20060728 |
| Marketing Category Name | NDA |
| Labeler Name | Aqua Pharmaceuticals, LLC. |
| Substance Name | KETOCONAZOLE |
| Strength Number | 20 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |