Tobramycin and Dexamethasone
- Product NDC
- 68071-2418
- 11-digit product format
- 680712418
- Labeler code
- 68071
- Product ID
- 68071-2418_4e061c56-47ec-aed6-e063-6394a90aae59
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tobramycin and Dexamethasone
- Listing expiration
- 2027-12-31
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 |
|---|
| 68071-2418-2 | Tobramycin and Dexamethasone | 2.5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 2.5 | | 2 |
| 68071-2418-2 | Tobramycin and Dexamethasone | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2418 | TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210527_c33e84ba-4c0c-f738-e053-2995a90aa20a.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 |
|---|
| 68071-2418-2 | 68071241802 | 1 BOTTLE, DROPPER in 1 CARTON (68071-2418-2) / 2.5 mL in 1 BOTTLE, DROPPER | 2021-05-26 | 0000-00-00 | No | No | Current |