Tobramycin
- Product NDC
- 0093-3750
- 11-digit product format
- 000933750
- Labeler code
- 0093
- Product ID
- 0093-3750_8aa98982-a156-4bc8-8d31-9a39b88808ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA210915
- Marketing category
- ANDA
- Marketing start
- 2020-09-15
- Marketing end
- 2026-06-30
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/4mL
- 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/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 1314763 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-3750-28 | Tobramycin | 7 in 1 CARTON | SOLUTION | 7 | | 6 |
| 0093-3750-28 | Tobramycin | 4 in 1 POUCH | SOLUTION | 4 | | 6 |
| 0093-3750-63 | Tobramycin | 4 in 1 POUCH | SOLUTION | 4 | | 6 |
| 0093-3750-63 | Tobramycin | 14 in 1 CARTON | SOLUTION | 14 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3750 | TOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250226_d03079d2-5617-4628-92b9-3caa757b22c0.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 |
|---|
| 0093-3750-28 | 00093375028 | 7 POUCH in 1 CARTON (0093-3750-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE | 7 pouch | 2020-09-15 | 2026-06-30 | No | No | Current |
| 0093-3750-63 | 00093375063 | 14 POUCH in 1 CARTON (0093-3750-63) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE | 14 pouch | 2020-09-15 | 2026-06-30 | No | No | Current |