Tobramycin
- Product NDC
- 68083-241
- 11-digit product format
- 680830241
- Labeler code
- 68083
- Product ID
- 68083-241_7dec68fc-8f9a-4a26-9578-81bb22a5a1b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA209346
- Marketing category
- ANDA
- Marketing start
- 2021-02-09
- 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 |
|---|
| 68083-241-01 | Tobramycin | 1 in 1 CARTON | INJECTION | 1 | | 7 |
| 68083-241-01 | Tobramycin | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 50 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-241 | TOBRAMYCIN INJECTION [GLAND PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230228_02b48684-168c-4cd9-8375-794206eff23e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-241-01 | 68083024101 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-241-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2021-02-09 | 0000-00-00 | No | No | Current |