Tobramycin
- Product NDC
- 68083-254
- 11-digit product format
- 680830254
- Labeler code
- 68083
- Product ID
- 68083-254_5af7f80d-4d6d-404f-9ff7-1a8315625d8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA209621
- Marketing category
- ANDA
- Marketing start
- 2021-02-11
- 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 | 313416, 597823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-254-01 | Tobramycin | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION | 2 | | 7 |
| 68083-254-25 | Tobramycin | 25 in 1 CARTON | INJECTION | 25 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-254 | TOBRAMYCIN INJECTION [GLAND PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230310_645d34d9-275d-428e-863d-ae15ad009c44.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 |
|---|
| 68083-254-01 | 68083025401 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | | | | | Historical |
| 68083-254-25 | 68083025425 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-254-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-254-01) | | 2021-02-11 | 0000-00-00 | No | No | Current |