Tobramycin
- Product NDC
- 60687-731
- 11-digit product format
- 606870731
- Labeler code
- 60687
- Product ID
- 60687-731_468bc4c2-5d73-2339-e063-6394a90ad327
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- American Health Packaging
- Application
- ANDA207136
- Marketing category
- ANDA
- Marketing start
- 2024-05-19
- Marketing end
- 2027-08-31
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/5mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tobramycin
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOBRAMYCIN | 300 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 348719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-731-79 | Tobramycin | 5 mL in 1 AMPULE | SOLUTION | 5 | | 4 |
| 60687-731-79 | Tobramycin | 1 in 1 POUCH | SOLUTION | 1 | | 4 |
| 60687-731-83 | Tobramycin | 30 in 1 CARTON | SOLUTION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-731 | TOBRAMYCIN SOLUTION [AMERICAN HEALTH PACKAGING] | 3 | Current NDC, 3 package rows | 20240519_f2f8bf02-57f8-4d34-937a-32411fc6bfba.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 |
|---|
| 60687-731-79 | 60687073179 | 5 mL in 1 AMPULE | 5 ml | | | | | Historical |
| 60687-731-83 | 60687073183 | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE | 30 pouch | 2024-05-19 | 2027-08-31 | No | No | Historical |