| Product NDC: | 55150-157 |
| Proprietary Name: | Levofloxacin |
| Non Proprietary Name: | Levofloxacin |
| Active Ingredient(s): | 750 mg/30mL & nbsp; Levofloxacin |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION, CONCENTRATE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55150-157 |
| Labeler Name: | AuroMedics Pharma LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202328 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130124 |
| Package NDC: | 55150-157-30 |
| Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (55150-157-30) > 30 mL in 1 VIAL, SINGLE-USE |
| NDC Code | 55150-157-30 |
| Proprietary Name | Levofloxacin |
| Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (55150-157-30) > 30 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 55150-157 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Levofloxacin |
| Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20130124 |
| Marketing Category Name | ANDA |
| Labeler Name | AuroMedics Pharma LLC |
| Substance Name | LEVOFLOXACIN |
| Strength Number | 750 |
| Strength Unit | mg/30mL |
| Pharmaceutical Classes |