TobraDex
- Product NDC
- 0078-0876
- 11-digit product format
- 000780876
- Labeler code
- 0078
- Product ID
- 0078-0876_11f2ad7a-2b97-4316-84b5-49fee866fa81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin and dexamethasone
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA050616
- Marketing category
- NDA
- Marketing start
- 1988-10-15
- Substance
- DEXAMETHASONE; TOBRAMYCIN
- Active strength
- 1; 3 mg/g; mg/g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 1 mg/g |
| TOBRAMYCIN | 3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, VZ8RRZ51VK |
| Rxcui | 208821, 309682 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0876-01 | TobraDex | 3.5 g in 1 TUBE | OINTMENT | 3.5 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0876 | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250226_7f310e0e-0d3b-493d-b6c4-238493a2a9b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0876-01 | 00078087601 | 3.5 g in 1 TUBE (0078-0876-01) | 3.5 g | 2020-10-27 | 0000-00-00 | No | No | Current |