| Product NDC: | 10122-820 |
| Proprietary Name: | BETHKIS |
| Non Proprietary Name: | tobramycin |
| Active Ingredient(s): | 300 mg/4mL & nbsp; tobramycin |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 10122-820 |
| Labeler Name: | Cornerstone Therapeutics Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA201820 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130415 |
| Package NDC: | 10122-820-56 |
| Package Description: | 14 POUCH in 1 CARTON (10122-820-56) > 4 AMPULE in 1 POUCH > 4 mL in 1 AMPULE (10122-820-04) |
| NDC Code | 10122-820-56 |
| Proprietary Name | BETHKIS |
| Package Description | 14 POUCH in 1 CARTON (10122-820-56) > 4 AMPULE in 1 POUCH > 4 mL in 1 AMPULE (10122-820-04) |
| Product NDC | 10122-820 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | tobramycin |
| Dosage Form Name | SOLUTION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20130415 |
| Marketing Category Name | NDA |
| Labeler Name | Cornerstone Therapeutics Inc. |
| Substance Name | TOBRAMYCIN |
| Strength Number | 300 |
| Strength Unit | mg/4mL |
| Pharmaceutical Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] |