TobraDex
- Product NDC
- 21695-628
- 11-digit product format
- 216950628
- Labeler code
- 21695
- Product ID
- 21695-628_fe08bcd5-4d14-4c2d-940c-b7968f9a89f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin and dexamethasone
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- NDA050616
- Marketing category
- NDA
- Marketing start
- 1988-09-28
- Marketing end
- 0000-00-00
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-628-35 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ac7-48b1-e053-8cdaa90a720a | TobraDex |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-628-35 | TobraDex | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-628-35 | GM - Gram | 21695-628 | c878679a-0b5e-4cfd-8efc-5909f92b3cd3 | 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 Dashboard NDC Coverage#
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 | Status |
|---|---|---|---|---|
| 21695-628-35 | 21695062835 | 3.5 g in 1 TUBE | 3.5 g | Historical |