Tobramycin
- Product NDC
- 68083-312
- 11-digit product format
- 680830312
- Labeler code
- 68083
- Product ID
- 68083-312_a13f2109-eb69-4d3a-9203-790cb6520e78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA211189
- Marketing category
- ANDA
- Marketing start
- 2021-05-18
- Substance
- TOBRAMYCIN SULFATE
- Active strength
- 1.2 g/30mL
- 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 | 1.2 g/30mL |
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 |
|---|
| 68083-312-01 | Tobramycin | 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, POWDER, LYOPHILIZED, | 30 | | 8 |
| 68083-312-06 | Tobramycin | 6 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 6 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-312 | TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20221021_38219f34-4859-428f-9ec1-06ead7604211.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 |
|---|
| 68083-312-01 | 68083031201 | 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | 30 ml | | | | | Historical |
| 68083-312-06 | 68083031206 | 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-312-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (68083-312-01) | | 2021-05-18 | 0000-00-00 | No | No | Current |