NDC 21695-458
Tobrex
Tobramycin
Tobrex is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Tobramycin.
| Product ID | 21695-458_3d4be22b-7a8c-4247-ac35-143611342de1 |
| NDC | 21695-458 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tobrex |
| Generic Name | Tobramycin |
| Dosage Form | Ointment |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 1981-11-25 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050555 |
| Labeler Name | Rebel Distributors Corp |
| Substance Name | TOBRAMYCIN |
| Active Ingredient Strength | 3 mg/g |
| Pharm Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 21695-458-35
3.5 g in 1 TUBE (21695-458-35)
| Marketing Start Date | 1981-11-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 21695-458-35 [21695045835]
Tobrex OINTMENT
| Marketing Category | NDA |
| Application Number | NDA050555 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 1981-11-25 |
| Inactivation Date | 2019-09-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TOBRAMYCIN | 3 mg/g |
OpenFDA Data
| SPL SET ID: | 3d4be22b-7a8c-4247-ac35-143611342de1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Aminoglycoside Antibacterial [EPC]
- Aminoglycosides [CS]
NDC Crossover Matching brand name "Tobrex" or generic name "Tobramycin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-0643 | Tobrex | tobramycin |
| 0065-0644 | TOBREX | tobramycin |
| 0078-0813 | TOBREX | tobramycin |
| 21695-458 | Tobrex | Tobrex |
| 10122-820 | BETHKIS | tobramycin |
| 0078-0494 | TOBI | Tobramycin |
| 0078-0630 | TOBI Podhaler | Tobramycin |
| 0093-3750 | Tobramycin | Tobramycin |
| 0093-4085 | Tobramycin | Tobramycin |
| 0404-7196 | Tobramycin | Tobramycin |
| 0409-3578 | TOBRAMYCIN | TOBRAMYCIN |
| 0703-9402 | Tobramycin | Tobramycin |
| 0781-7171 | Tobramycin | Tobramycin |
| 10544-883 | Tobramycin | Tobramycin |
| 13985-604 | Tobramycin | Tobramycin |
| 13985-743 | Tobramycin | Tobramycin |
| 17478-290 | Tobramycin | Tobramycin |
| 17478-340 | Tobramycin | Tobramycin |
Trademark Results [Tobrex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOBREX 73276380 1189092 Live/Registered |
Alcon Laboratories, Inc. 1980-09-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.