Tobramycin and Dexamethasone
- Product NDC
- 68071-4203
- 11-digit product format
- 680714203
- Labeler code
- 68071
- Product ID
- 68071-4203_1a3b96b0-10ad-9bb1-e063-6294a90ab279
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin and Dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA064134
- Marketing category
- ANDA
- Marketing start
- 1999-10-27
- Substance
- DEXAMETHASONE; TOBRAMYCIN
- Active strength
- 1; 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
- Tobramycin and Dexamethasone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 1 mg/mL |
| TOBRAMYCIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, VZ8RRZ51VK |
| Rxcui | 309683 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4203-5 | Tobramycin and Dexamethasone | 5 mL in 1 BOX | SUSPENSION/ DROPS | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4203 | TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240608_61693e79-81d1-3162-e053-2a91aa0ae925.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 |
|---|
| 68071-4203-5 | 68071420305 | 5 mL in 1 BOX (68071-4203-5) | 5 ml | 2017-12-28 | 0000-00-00 | No | No | Current |