Tobramycin
- Product NDC
- 10544-883
- 11-digit product format
- 105440883
- Labeler code
- 10544
- Product ID
- 10544-883_1622f31d-3a6a-2887-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA064096
- Marketing category
- ANDA
- Marketing start
- 2015-05-15
- Marketing end
- 0000-00-00
- Substance
- TOBRAMYCIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 10544-883-99 | Tobramycin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
| 10544-883-99 | Tobramycin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOBRAMYCIN | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| TOBRAMYCIN | ACTIVE MOIETY | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM SULFATE | INACTIVE INGREDIENT | 0YPR65R21J | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| TYLOXAPOL | INACTIVE INGREDIENT | Y27PUL9H56 | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-883 | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20150515_1622f31d-3a69-2887-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 10544-883-99 | 10544088399 | 5 mL in 1 BOTTLE, DROPPER | 5 ml | Historical |