Tobramycin
- Product NDC
- 68083-374
- 11-digit product format
- 680830374
- Labeler code
- 68083
- Product ID
- 68083-374_f43b227e-3e24-428d-bef1-4f32628a786e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA212628
- Marketing category
- ANDA
- Marketing start
- 2021-03-09
- Substance
- TOBRAMYCIN
- Active strength
- 3 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 | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 313415 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-374-01 | Tobramycin | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 5 | | 7 |
| 68083-374-01 | Tobramycin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-374 | TOBRAMYCIN SOLUTION/ DROPS [GLAND PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20210728_f8c92d73-711a-423f-bf34-bdec4464828e.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 |
|---|
| 68083-374-01 | 68083037401 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-374-01) / 5 mL in 1 BOTTLE, PLASTIC | 2021-03-09 | 0000-00-00 | No | No | Current |