TOBREX
- Product NDC
- 0065-0644
- 11-digit product format
- 000650644
- Labeler code
- 0065
- Product ID
- 0065-0644_98cbf372-1955-408c-8891-04dba817ef14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA050555
- Marketing category
- NDA
- Marketing start
- 1981-06-28
- Marketing end
- 0000-00-00
- Substance
- TOBRAMYCIN
- Active strength
- 3 mg/g
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0065-0644-35 | GM - Gram | 0065-0644 | 24ae6212-ff8a-4b89-a629-0995489e351c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| tobramycin | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| TOBRAMYCIN | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA] | 1 | |
| tobramycin | ACTIVE MOIETY | VZ8RRZ51VK | TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| TOBRAMYCIN | ACTIVE MOIETY | VZ8RRZ51VK | TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA] | 1 | |
| chlorobutanol | INACTIVE INGREDIENT | HM4YQM8WRC | TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| chlorobutanol | INACTIVE INGREDIENT | HM4YQM8WRC | TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| petrolatum | INACTIVE INGREDIENT | 4T6H12BN9U | TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313414 | tobramycin 0.3 % Ophthalmic Ointment | PSN | 3d4be22b-7a8c-4247-ac35-143611342de1 | 1 |
| 313414 | tobramycin 0.3 % Ophthalmic Ointment | PSN | b1d58360-96b4-4d23-82aa-3e4872dc0136 | 1 |
| 207850 | Tobrex 0.3 % Ophthalmic Ointment | PSN | 3d4be22b-7a8c-4247-ac35-143611342de1 | 1 |
| 207850 | Tobrex 0.3 % Ophthalmic Ointment | PSN | b1d58360-96b4-4d23-82aa-3e4872dc0136 | 1 |
| 207850 | tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobrex] | SBD | 3d4be22b-7a8c-4247-ac35-143611342de1 | 1 |
| 207850 | tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobrex] | SBD | b1d58360-96b4-4d23-82aa-3e4872dc0136 | 1 |
| 313414 | tobramycin 0.003 MG/MG Ophthalmic Ointment | SCD | 3d4be22b-7a8c-4247-ac35-143611342de1 | 1 |
| 313414 | tobramycin 0.003 MG/MG Ophthalmic Ointment | SCD | b1d58360-96b4-4d23-82aa-3e4872dc0136 | 1 |
| 313414 | tobramycin 0.3 % Ophthalmic Ointment | SY | 3d4be22b-7a8c-4247-ac35-143611342de1 | 1 |
| 313414 | tobramycin 0.3 % Ophthalmic Ointment | SY | b1d58360-96b4-4d23-82aa-3e4872dc0136 | 1 |
| 207850 | Tobrex 0.003 MG/MG Ophthalmic Ointment | SY | 3d4be22b-7a8c-4247-ac35-143611342de1 | 1 |
| 207850 | Tobrex 0.003 MG/MG Ophthalmic Ointment | SY | b1d58360-96b4-4d23-82aa-3e4872dc0136 | 1 |
| 207850 | Tobrex 0.3 % Ophthalmic Ointment | SY | 3d4be22b-7a8c-4247-ac35-143611342de1 | 1 |
| 207850 | Tobrex 0.3 % Ophthalmic Ointment | SY | b1d58360-96b4-4d23-82aa-3e4872dc0136 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0065-0644-35 | 00065064435 | 3.5 g in 1 TUBE (0065-0644-35) | 3.5 g | 1981-06-28 | 0000-00-00 | No | No | Current |