Tobramycin
- Product NDC
- 67457-428
- 11-digit product format
- 674570428
- Labeler code
- 67457
- Product ID
- 67457-428_7418acd9-03c9-40ed-bac0-1e0702c8114d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA065407
- Marketing category
- ANDA
- Marketing start
- 2014-02-19
- Substance
- TOBRAMYCIN SULFATE
- Active strength
- 40 mg/mL
- 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 SULFATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HJT0RXD7JK |
| Rxcui | 597823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-428-00 | Tobramycin | 30 mL in 1 VIAL | INJECTION | 30 | | 7 |
| 67457-428-30 | Tobramycin | 10 in 1 CARTON | INJECTION | 10 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-428 | TOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230105_ac8134d9-a726-4508-b8b9-a536ef17243d.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 |
|---|
| 67457-428-00 | 67457042800 | 30 mL in 1 VIAL | 30 ml | | | | | Historical |
| 67457-428-30 | 67457042830 | 10 VIAL in 1 CARTON (67457-428-30) / 30 mL in 1 VIAL (67457-428-00) | 10 vial | 2014-02-19 | 0000-00-00 | No | No | Current |