Tobradex ST
- Product NDC
- 82667-011
- 11-digit product format
- 826670011
- Labeler code
- 82667
- Product ID
- 82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin / dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Harrow Eye, LLC
- Application
- NDA050818
- Marketing category
- NDA
- Marketing start
- 2025-03-31
- Substance
- DEXAMETHASONE; TOBRAMYCIN
- Active strength
- .5; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tobradex ST
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | .5 mg/mL |
| TOBRAMYCIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, VZ8RRZ51VK |
| Rxcui | 849115, 1011080 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82667-011-00 | Tobradex ST | 1 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 1 | | 3 |
| 82667-011-00 | Tobradex ST | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 82667-011-05 | Tobradex ST | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 3 |
| 82667-011-05 | Tobradex ST | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82667-011 | TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION/ DROPS [HARROW EYE, LLC] | 3 | Current NDC, 4 package rows | 20250403_3b99dbb3-ac84-4d0d-b30f-a5db44fdc316.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82667-011-00 | 82667001100 | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER | 2025-03-31 | No | No | Historical |
| 82667-011-05 | 82667001105 | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER | 2025-03-31 | No | No | Historical |