Tobramycin
- Product NDC
- 17478-290
- 11-digit product format
- 174780290
- Labeler code
- 17478
- Product ID
- 17478-290_8893a898-9495-4eb6-800a-ede9227c83d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA064096
- Marketing category
- ANDA
- Marketing start
- 1996-01-31
- Marketing end
- 0000-00-00
- Substance
- TOBRAMYCIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 17478-290-10 | Tobramycin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 7 |
| 17478-290-10 | Tobramycin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 17478-290-20 | Tobramycin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 17478-290-20 | Tobramycin | 2 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Tobramycin | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| Tobramycin | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| TOBRAMYCIN | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| Tobramycin | ACTIVE MOIETY | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| Tobramycin | ACTIVE MOIETY | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| TOBRAMYCIN | ACTIVE MOIETY | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 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 | |
| Boric Acid | INACTIVE INGREDIENT | R57ZHV85D4 | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| Boric Acid | INACTIVE INGREDIENT | R57ZHV85D4 | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| SODIUM SULFATE | INACTIVE INGREDIENT | 0YPR65R21J | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| sodium Sulfate | INACTIVE INGREDIENT | 0YPR65R21J | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| sodium Sulfate | INACTIVE INGREDIENT | 0YPR65R21J | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| Sulfuric Acid | INACTIVE INGREDIENT | O40UQP6WCF | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| Sulfuric Acid | INACTIVE INGREDIENT | O40UQP6WCF | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| Tyloxapol | INACTIVE INGREDIENT | Y27PUL9H56 | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| Tyloxapol | INACTIVE INGREDIENT | Y27PUL9H56 | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 1 | |
| TYLOXAPOL | INACTIVE INGREDIENT | Y27PUL9H56 | TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] | 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 |
|---|
| 17478-290 | TOBRAMYCIN SOLUTION/ DROPS [AKORN] | 7 | Legacy NDC, 4 package rows | 20220919_c91db5e0-f6b8-40d7-b307-b24073b9705e.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 |
|---|
| 17478-290-10 | 17478029010 | 1 BOTTLE, DROPPER in 1 CARTON (17478-290-10) > 5 mL in 1 BOTTLE, DROPPER | 1996-01-31 | 0000-00-00 | No | No | Current |
| 17478-290-20 | 17478029020 | 1 BOTTLE, DROPPER in 1 CARTON (17478-290-20) > 2 mL in 1 BOTTLE, DROPPER | 1996-01-31 | 0000-00-00 | No | No | Current |