| Product NDC: | 0054-0002 |
| Proprietary Name: | Fluconazole |
| Non Proprietary Name: | Fluconazole |
| Active Ingredient(s): | 10 mg/mL & nbsp; Fluconazole |
| Administration Route(s): | ORAL |
| Dosage Form(s): | POWDER, FOR SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-0002 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076246 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20040729 |
| Package NDC: | 0054-0002-85 |
| Package Description: | 350 mL in 1 BOTTLE, PLASTIC (0054-0002-85) |
| NDC Code | 0054-0002-85 |
| Proprietary Name | Fluconazole |
| Package Description | 350 mL in 1 BOTTLE, PLASTIC (0054-0002-85) |
| Product NDC | 0054-0002 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Fluconazole |
| Dosage Form Name | POWDER, FOR SUSPENSION |
| Route Name | ORAL |
| Start Marketing Date | 20040729 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | FLUCONAZOLE |
| Strength Number | 10 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |