Tobramycin and Dexamethasone
- Product NDC
- 68788-4081
- 11-digit product format
- 687884081
- Labeler code
- 68788
- Product ID
- 68788-4081_8a143864-e36b-49bf-91b4-c6cc1a928031
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin and Dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- NDA050592
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2026-02-26
- Substance
- DEXAMETHASONE; TOBRAMYCIN
- Active strength
- 1; 3 mg/mL; mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tobramycin and Dexamethasone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 1 mg/mL |
| TOBRAMYCIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, VZ8RRZ51VK |
| Rxcui | 309683 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4081-5 | Tobramycin and Dexamethasone | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 1 |
| 68788-4081-5 | Tobramycin and Dexamethasone | 5 mL in 1 BOTTLE | SUSPENSION/ DROPS | 5 | | 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 |
|---|
| 68788-4081-5 | 68788408105 | 1 BOTTLE in 1 CARTON (68788-4081-5) / 5 mL in 1 BOTTLE | 1 bottle | 2026-02-26 | No | No | Historical |