Tobramycin
- Product NDC
- 85766-189
- 11-digit product format
- 857660189
- Labeler code
- 85766
- Product ID
- 85766-189_4d6e6b1d-8143-3586-e063-6394a90a4d97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sportpharm LLC
- Application
- ANDA207444
- Marketing category
- ANDA
- Marketing start
- 2020-08-11
- Substance
- TOBRAMYCIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tobramycin
- Listing expiration
- 2027-12-31
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 |
|---|
| 85766-189-05 | Tobramycin | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
| 85766-189-05 | Tobramycin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-189-05 | 85766018905 | 1 BOTTLE in 1 CARTON (85766-189-05) / 5 mL in 1 BOTTLE | 1 bottle | 2026-03-20 | No | No | Current |