Tobradex ST
- Product NDC
- 71776-035
- 11-digit product format
- 717760035
- Labeler code
- 71776
- Product ID
- 71776-035_2bd6e870-446a-02f4-e063-6394a90a27b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin / dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Eyevance Pharmaceuticals, LLC
- Application
- NDA050818
- Marketing category
- NDA
- Marketing start
- 2021-05-19
- 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 |
|---|
| 71776-035-01 | Tobradex ST | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 9 |
| 71776-035-01 | Tobradex ST | 1 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 1 | | 9 |
| 71776-035-05 | Tobradex ST | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 9 |
| 71776-035-05 | Tobradex ST | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71776-035 | TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION/ DROPS [EYEVANCE PHARMACEUTICALS, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250119_c2d7325e-4f58-5590-e053-2a95a90ace1b.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 |
|---|
| 71776-035-01 | 71776003501 | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER | 2021-05-19 | 0000-00-00 | No | No | Current |
| 71776-035-05 | 71776003505 | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER | 2021-05-19 | 0000-00-00 | No | No | Current |