Tobramycin
- Product NDC
- 67877-678
- 11-digit product format
- 678770678
- Labeler code
- 67877
- Product ID
- 67877-678_25c12569-0ae1-4117-a945-edfc5457e525
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA212848
- Marketing category
- ANDA
- Marketing start
- 2021-04-02
- 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
- Tobramycin
- 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 | 348719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-678-69 | Tobramycin | 5 mL in 1 AMPULE | SOLUTION | 5 | | 8 |
| 67877-678-69 | Tobramycin | 7 in 1 POUCH | SOLUTION | 7 | | 8 |
| 67877-678-70 | Tobramycin | 56 in 1 CARTON | SOLUTION | 56 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-678 | TOBRAMYCIN SOLUTION [ASCEND LABORATORIES, LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240111_845e3328-fffa-44eb-b78a-3607c05fdd55.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 |
|---|
| 67877-678-69 | 67877067869 | 5 mL in 1 AMPULE | 5 ml | | | | | Historical |
| 67877-678-70 | 67877067870 | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE | 56 pouch | 2021-04-02 | 0000-00-00 | No | No | Current |