 
                        | Product NDC: | 0456-4300 | 
| Proprietary Name: | Monurol | 
| Non Proprietary Name: | Fosfomycin tromethamine | 
| Active Ingredient(s): | 3 g/1 & nbsp; Fosfomycin tromethamine | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | POWDER | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0456-4300 | 
| Labeler Name: | Forest Laboratories | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA050717 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 19961219 | 
| Package NDC: | 0456-4300-08 | 
| Package Description: | 1 POWDER in 1 PACKET (0456-4300-08) | 
| NDC Code | 0456-4300-08 | 
| Proprietary Name | Monurol | 
| Package Description | 1 POWDER in 1 PACKET (0456-4300-08) | 
| Product NDC | 0456-4300 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Fosfomycin tromethamine | 
| Dosage Form Name | POWDER | 
| Route Name | ORAL | 
| Start Marketing Date | 19961219 | 
| Marketing Category Name | NDA | 
| Labeler Name | Forest Laboratories | 
| Substance Name | FOSFOMYCIN TROMETHAMINE | 
| Strength Number | 3 | 
| Strength Unit | g/1 | 
| Pharmaceutical Classes |