TobraDex
- Product NDC
- 0065-0648
- 11-digit product format
- 000650648
- Labeler code
- 0065
- Product ID
- 0065-0648_ab313ed7-5b46-4426-a9fb-e40af786394d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin and dexamethasone
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA050616
- Marketing category
- NDA
- Marketing start
- 1988-10-15
- Marketing end
- 2022-06-30
- Substance
- TOBRAMYCIN; DEXAMETHASONE
- Active strength
- 3 mg/g; mg/g
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0065-0648-35 | GM - Gram | 0065-0648 | 361de8dd-64b8-4892-a15e-02a590282310 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| dexamethasone | ACTIVE INGREDIENT | 7S5I7G3JQL | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| tobramycin | ACTIVE INGREDIENT | VZ8RRZ51VK | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| dexamethasone | ACTIVE MOIETY | 7S5I7G3JQL | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| tobramycin | ACTIVE MOIETY | VZ8RRZ51VK | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| chlorobutanol | INACTIVE INGREDIENT | HM4YQM8WRC | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 208821 | TobraDex 0.3 % / 0.1 % Ophthalmic Ointment | PSN | fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 | 1 |
| 309682 | tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Ointment | PSN | fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 | 1 |
| 208821 | dexamethasone 0.001 MG/MG / tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobradex] | SBD | fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 | 1 |
| 309682 | dexamethasone 0.001 MG/MG / tobramycin 0.003 MG/MG Ophthalmic Ointment | SCD | fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 | 1 |
| 309682 | dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Ointment | SY | fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 | 1 |
| 208821 | Tobradex (tobramycin 0.3 % / dexamethasone 0.1 % ) Ophthalmic Ointment | SY | fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0065-0648-35 | 00065064835 | 1 TUBE in 1 CARTON (0065-0648-35) > 3.5 g in 1 TUBE | 1 tube | 1988-10-15 | 2022-06-30 | No | No | Current |