Tobramycin
- Product NDC
- 17478-340
- 11-digit product format
- 174780340
- Labeler code
- 17478
- Product ID
- 17478-340_bc74ed3a-ecf1-43bf-b36c-1958d0578a8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Akorn
- Application
- ANDA201422
- Marketing category
- ANDA
- Marketing start
- 2014-05-29
- Marketing end
- 0000-00-00
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/5mL
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f297c7c1-845a-4369-8c02-c51b92d6ae8e | Product name | 3 | 20240725 |
| 551d952d-4ce2-24f0-9ab0-630ad9aae596 | Product name | 2 | 20231211 |
| 941f67d9-7f03-56d2-750c-36de24f654db | Product name | 3 | 20221117 |
| 9cfa145f-dbe9-bc02-83c2-692786ef6676 | Product name | 9 | 20210928 |
| 2f9713b8-5e7e-bbcc-b364-1b2c27a63796 | Product name | 4 | 20210903 |
| 32a533bc-01c7-2b9f-bbf7-ecfb0d964277 | Product name | 4 | 20210625 |
| 9f5124fb-08b0-4c3e-8e12-a1a6ff310cba | Product name | 1 | 20150309 |
| 745a62af-e1c0-4ca3-6d6e-2b6455b903be | Product name | 1 | 20140508 |
| 9ea85abb-fa68-5da6-ab60-2c7eef579000 | Product name | 1 | 20140508 |
| aa1cd319-ece7-51f7-3a9d-52a64f5f4e81 | Product name | 1 | 20140508 |
| d029211e-5e6b-725f-3696-ac6ff77da222 | Product name | 1 | 20140508 |
| ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17478-340-38 | 2024-01-30 | C162847 | 48780-1 | 1030e365-50f8-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use TOBRAMYCIN INHALATION SOLUTION safely and effectively. See full prescribing information for TOBRAMYCIN INHALATION SOLUTION. TOBRAMYCIN inhalation solution, for oral inhalation use Initial U.S. Approval: 1975 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-340-38 | ML - Milliliter | 17478-340 | 42ccda22-7cde-4e29-9ef1-c24f8d7e2d5e | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Tobramycin | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBRAMYCIN SOLUTION [AKORN, INC. ] | 8 | |
| Tobramycin | ACTIVE MOIETY | VZ8RRZ51VK | TOBRAMYCIN SOLUTION [AKORN, INC. ] | 8 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | TOBRAMYCIN SOLUTION [AKORN, INC. ] | 8 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TOBRAMYCIN SOLUTION [AKORN, INC. ] | 8 | |
| Sulfuric Acid | INACTIVE INGREDIENT | O40UQP6WCF | TOBRAMYCIN SOLUTION [AKORN, INC. ] | 8 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | TOBRAMYCIN SOLUTION [AKORN, INC. ] | 8 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 17478-340-38 | 17478034038 | 14 POUCH in 1 CARTON (17478-340-38) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE | 14 pouch | 2014-05-29 | 0000-00-00 | No | No | Current |