| Product NDC: | 50458-170 |
| Proprietary Name: | LEVAQUIN |
| Non Proprietary Name: | levofloxacin |
| Active Ingredient(s): | 25 mg/mL & nbsp; levofloxacin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50458-170 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021721 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20041021 |
| Package NDC: | 50458-170-01 |
| Package Description: | 480 mL in 1 BOTTLE (50458-170-01) |
| NDC Code | 50458-170-01 |
| Proprietary Name | LEVAQUIN |
| Package Description | 480 mL in 1 BOTTLE (50458-170-01) |
| Product NDC | 50458-170 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | levofloxacin |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20041021 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | LEVOFLOXACIN |
| Strength Number | 25 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] |