| Product NDC: | 54868-4327 |
| Proprietary Name: | Floxin |
| Non Proprietary Name: | ofloxacin |
| Active Ingredient(s): | 3 mg/mL & nbsp; ofloxacin |
| Administration Route(s): | AURICULAR (OTIC) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-4327 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020799 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20000911 |
| Package NDC: | 54868-4327-0 |
| Package Description: | 5 POUCH in 1 CARTON (54868-4327-0) > 2 VIAL, SINGLE-USE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-USE |
| NDC Code | 54868-4327-0 |
| Proprietary Name | Floxin |
| Package Description | 5 POUCH in 1 CARTON (54868-4327-0) > 2 VIAL, SINGLE-USE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 54868-4327 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ofloxacin |
| Dosage Form Name | SOLUTION |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20000911 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | OFLOXACIN |
| Strength Number | 3 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] |