Tobramycin
- Product NDC
- 53002-9232
- 11-digit product format
- 530029232
- Labeler code
- 53002
- Product ID
- 53002-9232_c8ae66e4-6cd2-4cc7-8c5c-a1c8096ac8e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA062535
- Marketing category
- ANDA
- Marketing start
- 1995-01-09
- 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
- 2021-12-31
- 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 |
|---|---|---|---|---|---|
| 53002-9232-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-2400-f424-e053-dadaa90a57ce | Tobramycin Ophthalmic Solution, USP 0.3% Rx Only |
| 53002-9232-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-2400-f424-e053-dadaa90a57ce | Tobramycin Ophthalmic Solution, USP 0.3% Rx Only |
| 53002-9232-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-2400-f424-e053-dadaa90a57ce | Tobramycin Ophthalmic Solution, USP 0.3% Rx Only |
| 53002-9232-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-2400-f424-e053-dadaa90a57ce | Tobramycin Ophthalmic Solution, USP 0.3% Rx Only |
| 53002-9232-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2400-f424-e053-dadaa90a57ce | Tobramycin Ophthalmic Solution, USP 0.3% Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-9232-1 | Tobramycin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-9232 | TOBRAMYCIN SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_612c3958-bb10-4fc9-8506-6533798fc8cb.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313415 | tobramycin 0.3 % Ophthalmic Solution | PSN | 612c3958-bb10-4fc9-8506-6533798fc8cb | 5 |
| 313415 | tobramycin 3 MG/ML Ophthalmic Solution | SCD | 612c3958-bb10-4fc9-8506-6533798fc8cb | 5 |
| 313415 | tobramycin 0.3 % Ophthalmic Solution | SY | 612c3958-bb10-4fc9-8506-6533798fc8cb | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-9232-1 | 53002923201 | 5 mL in 1 BOTTLE, DROPPER (53002-9232-1) | 5 ml | 2018-10-01 | 0000-00-00 | No | No | Current |