TobraDex
- Product NDC
- 0078-0953
- 11-digit product format
- 000780953
- Labeler code
- 0078
- Product ID
- 0078-0953_c662bb23-f30c-451d-aa6c-f3f26fb72377
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin and dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA050592
- Marketing category
- NDA
- Marketing start
- 1988-09-15
- Marketing end
- 0000-00-00
- Substance
- DEXAMETHASONE; TOBRAMYCIN
- Active strength
- 1 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0953 | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] | 2 | Legacy NDC | 20230420_c662bb23-f30c-451d-aa6c-f3f26fb72377.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0953-25 | 00078095325 | 5 mL in 1 BOTTLE (0078-0953-25) | 5 ml | 2022-01-24 | 0000-00-00 | No | No | Current |
| 0078-0953-26 | 00078095326 | 10 mL in 1 BOTTLE (0078-0953-26) | 10 ml | 2022-01-24 | 0000-00-00 | No | No | Current |
| 0078-0953-40 | 00078095340 | 2.5 mL in 1 BOTTLE (0078-0953-40) | 2.5 ml | 2022-01-24 | 0000-00-00 | No | No | Current |