| Product NDC: | 68258-3998 | 
| Proprietary Name: | Ketoconazole | 
| Non Proprietary Name: | Ketoconazole | 
| Active Ingredient(s): | 20 mg/g & nbsp; Ketoconazole | 
| Administration Route(s): | TOPICAL | 
| Dosage Form(s): | CREAM | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 68258-3998 | 
| Labeler Name: | Dispensing Solutions, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA075638 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20021218 | 
| Package NDC: | 68258-3998-3 | 
| Package Description: | 1 TUBE in 1 CARTON (68258-3998-3) > 30 g in 1 TUBE | 
| NDC Code | 68258-3998-3 | 
| Proprietary Name | Ketoconazole | 
| Package Description | 1 TUBE in 1 CARTON (68258-3998-3) > 30 g in 1 TUBE | 
| Product NDC | 68258-3998 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Ketoconazole | 
| Dosage Form Name | CREAM | 
| Route Name | TOPICAL | 
| Start Marketing Date | 20021218 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Dispensing Solutions, Inc. | 
| Substance Name | KETOCONAZOLE | 
| Strength Number | 20 | 
| Strength Unit | mg/g | 
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |