TOBI
- Product NDC
- 49502-345
- 11-digit product format
- 495020345
- Labeler code
- 49502
- Product ID
- 49502-345_99c630df-5e03-4944-8225-26940d0ae737
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- ORAL; RESPIRATORY (INHALATION)
- Labeler
- Viatris Specialty LLC
- Application
- NDA050753
- Marketing category
- NDA
- Marketing start
- 2022-06-23
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/5mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOBI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOBRAMYCIN | 300 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 213194, 348719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49502-345-73 | TOBI | 56 in 1 CARTON | SOLUTION | 56 | | 6 |
| 49502-345-99 | TOBI | 4 in 1 POUCH | SOLUTION | 4 | | 6 |
| 49502-345-99 | TOBI | 5 mL in 1 AMPULE | SOLUTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49502-345 | TOBI (TOBRAMYCIN) SOLUTION [VIATRIS SPECIALTY LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250213_6a3c3871-1d3a-44d6-8be3-526b30123ef7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49502-345-73 | 49502034573 | 56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE | 56 pouch | 2022-06-23 | 0000-00-00 | No | No | Current |
| 49502-345-99 | 49502034599 | 4 in 1 POUCH | | | | | | Historical |