TOBI Podhaler is a Oral; Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Tobramycin.
| Product ID | 0078-0630_21fcb4b7-b59c-4c0c-b87e-377f0ad5753b |
| NDC | 0078-0630 |
| Product Type | Human Prescription Drug |
| Proprietary Name | TOBI Podhaler |
| Generic Name | Tobramycin |
| Dosage Form | Capsule |
| Route of Administration | ORAL; RESPIRATORY (INHALATION) |
| Marketing Start Date | 2013-03-22 |
| Marketing Category | NDA / NDA |
| Application Number | NDA201688 |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | TOBRAMYCIN |
| Active Ingredient Strength | 28 mg/1 |
| Pharm Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2013-03-22 |
| Marketing End Date | 2022-07-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA201688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-03-22 |
| Marketing Category | NDA |
| Application Number | NDA201688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-03-22 |
| Marketing Category | NDA |
| Application Number | NDA201688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-03-22 |
| Marketing Category | NDA |
| Application Number | NDA201688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-03-22 |
| Marketing Category | NDA |
| Application Number | NDA201688 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-03-22 |
| Ingredient | Strength |
|---|---|
| TOBRAMYCIN | 28 mg/1 |
| SPL SET ID: | 625a4499-4e46-4f5a-8d0c-d104f520d97e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0078-0630 | TOBI Podhaler | Tobramycin |
| 49502-346 | TOBI Podhaler | TOBI Podhaler |
| 10122-820 | BETHKIS | tobramycin |
| 0078-0494 | TOBI | Tobramycin |
| 0093-3750 | Tobramycin | Tobramycin |
| 0093-4085 | Tobramycin | Tobramycin |
| 0404-7196 | Tobramycin | Tobramycin |
| 0409-3578 | TOBRAMYCIN | TOBRAMYCIN |
| 0703-9402 | Tobramycin | Tobramycin |
| 0781-7171 | Tobramycin | Tobramycin |
| 10544-883 | Tobramycin | Tobramycin |
| 13985-604 | Tobramycin | Tobramycin |
| 13985-743 | Tobramycin | Tobramycin |
| 17478-290 | Tobramycin | Tobramycin |
| 17478-340 | Tobramycin | Tobramycin |
| 0065-0643 | Tobrex | tobramycin |
| 0065-0644 | TOBREX | tobramycin |
| 0078-0813 | TOBREX | tobramycin |