| Product NDC: | 0078-0494 |
| Proprietary Name: | TOBI |
| Non Proprietary Name: | Tobramycin |
| Active Ingredient(s): | 300 mg/5mL & nbsp; Tobramycin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0494 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA050753 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19971222 |
| Package NDC: | 0078-0494-71 |
| Package Description: | 56 AMPULE in 1 CARTON (0078-0494-71) > 5 mL in 1 AMPULE (0078-0494-61) |
| NDC Code | 0078-0494-71 |
| Proprietary Name | TOBI |
| Package Description | 56 AMPULE in 1 CARTON (0078-0494-71) > 5 mL in 1 AMPULE (0078-0494-61) |
| Product NDC | 0078-0494 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Tobramycin |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19971222 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | TOBRAMYCIN |
| Strength Number | 300 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] |