Tobramycin
- Product NDC
- 13985-604
- 11-digit product format
- 139850604
- Labeler code
- 13985
- Product ID
- 13985-604_2cf0b9a2-7c56-409e-8739-f3ed34fcb0d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- MWI
- Application
- ANDA064096
- Marketing category
- ANDA
- Marketing start
- 2015-03-27
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f297c7c1-845a-4369-8c02-c51b92d6ae8e | Product name | 3 | 20240725 |
| 551d952d-4ce2-24f0-9ab0-630ad9aae596 | Product name | 2 | 20231211 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
|---|---|---|---|---|---|
| 13985-604-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4a66-111a-e063-dadaa90a10e2 | 49dbd938-6c66-4835-af7f-923267f4568d |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13985-604-05 | Tobramycin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 5 | |
| 13985-604-05 | Tobramycin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Tobramycin | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Tobramycin | ACTIVE MOIETY | VZ8RRZ51VK | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Boric Acid | INACTIVE INGREDIENT | R57ZHV85D4 | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Sodium Sulfate | INACTIVE INGREDIENT | 0YPR65R21J | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Sulfuric Acid | INACTIVE INGREDIENT | O40UQP6WCF | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Tyloxapol | INACTIVE INGREDIENT | Y27PUL9H56 | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | TOBRAMYCIN SOLUTION/ DROPS [MWI] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313415 | tobramycin 0.3 % Ophthalmic Solution | PSN | 49dbd938-6c66-4835-af7f-923267f4568d | 5 |
| 313415 | tobramycin 3 MG/ML Ophthalmic Solution | SCD | 49dbd938-6c66-4835-af7f-923267f4568d | 5 |
| 313415 | tobramycin 0.3 % Ophthalmic Solution | SY | 49dbd938-6c66-4835-af7f-923267f4568d | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 13985-604-05 | 13985060405 | 1 BOTTLE, DROPPER in 1 CARTON (13985-604-05) > 5 mL in 1 BOTTLE, DROPPER | 2015-03-27 | 0000-00-00 | No | No | Current |