TOBREX
- Product NDC
- 0078-0813
- 11-digit product format
- 000780813
- Labeler code
- 0078
- Product ID
- 0078-0813_5e274c59-a22a-43a1-a3bd-b4f128dbee31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA050555
- Marketing category
- NDA
- Marketing start
- 1981-06-28
- Substance
- TOBRAMYCIN
- Active strength
- 3 mg/g
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOBREX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOBRAMYCIN | 3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 207850, 313414 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0813-01 | TOBREX | 3.5 g in 1 TUBE | OINTMENT | 3.5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0813 | TOBREX (TOBRAMYCIN) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250226_5b66bba3-cf97-4a9c-b618-ba5f277f20f6.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 |
|---|
| 0078-0813-01 | 00078081301 | 3.5 g in 1 TUBE (0078-0813-01) | 3.5 g | 2022-03-08 | 0000-00-00 | No | No | Current |