Tobramycin Inhalation Solution
- Product NDC
- 16714-119
- 11-digit product format
- 167140119
- Labeler code
- 16714
- Product ID
- 16714-119_ad71fb36-9238-ab3b-a5c4-9d284a63b27d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin Inhalation Solution
- Dosage form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Labeler
- NorthStar RxLLC
- Application
- ANDA207080
- Marketing category
- ANDA
- Marketing start
- 2020-05-21
- Marketing end
- 0000-00-00
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/5mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-119-02 | Tobramycin Inhalation Solution | 5 mL in 1 AMPULE | INHALANT | 5 | | 6 |
| 16714-119-03 | Tobramycin Inhalation Solution | 14 in 1 CARTON | INHALANT | 14 | | 6 |
| 16714-119-03 | Tobramycin Inhalation Solution | 4 in 1 POUCH | INHALANT | 4 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-119 | TOBRAMYCIN INHALATION SOLUTION INHALANT [NORTHSTAR RXLLC] | 6 | Legacy NDC, 3 package rows | 20241219_3d044738-a715-fdee-7849-521e8981e6ec.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 |
|---|
| 16714-119-02 | 16714011902 | 5 mL in 1 AMPULE | 5 ml | | | | | Historical |
| 16714-119-03 | 16714011903 | 14 POUCH in 1 CARTON (16714-119-03) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE (16714-119-02) | 14 pouch | 2020-05-21 | 0000-00-00 | No | No | Current |