TobraDex
- Product NDC
- 0065-0647
- 11-digit product format
- 000650647
- Labeler code
- 0065
- Product ID
- 0065-0647_d9197956-b1ac-4f59-a6ab-679e4ac76706
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin and dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA050592
- Marketing category
- NDA
- Marketing start
- 1988-09-15
- Marketing end
- 0000-00-00
- Substance
- DEXAMETHASONE; TOBRAMYCIN
- Active strength
- 1 mg/mL; mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 0065-0647-05 | ML - Milliliter | 0065-0647 | 4211f1b8-db69-4229-b270-c2542cb50eaa | 1 | 2012-07-24 |
| 0065-0647-10 | ML - Milliliter | 0065-0647 | 94230620-70ec-4165-b8c4-95ac977e47df | 1 | 2012-07-24 |
| 0065-0647-25 | ML - Milliliter | 0065-0647 | 276e2de1-e78c-4ca2-afb7-304a6c844a3c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 208813 | TobraDex 0.3 % / 0.1 % Ophthalmic Suspension | PSN | 2a2259ee-05e4-4785-ba75-5946132debf3 | 1 |
| 208813 | TobraDex 0.3 % / 0.1 % Ophthalmic Suspension | PSN | 330ac1f7-d583-454d-96bf-37c5af31a369 | 1 |
| 309683 | tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Suspension | PSN | 2a2259ee-05e4-4785-ba75-5946132debf3 | 1 |
| 309683 | tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Suspension | PSN | 330ac1f7-d583-454d-96bf-37c5af31a369 | 1 |
| 208813 | dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [Tobradex] | SBD | 2a2259ee-05e4-4785-ba75-5946132debf3 | 1 |
| 208813 | dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [Tobradex] | SBD | 330ac1f7-d583-454d-96bf-37c5af31a369 | 1 |
| 309683 | dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension | SCD | 2a2259ee-05e4-4785-ba75-5946132debf3 | 1 |
| 309683 | dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension | SCD | 330ac1f7-d583-454d-96bf-37c5af31a369 | 1 |
| 309683 | dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Suspension | SY | 2a2259ee-05e4-4785-ba75-5946132debf3 | 1 |
| 309683 | dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Suspension | SY | 330ac1f7-d583-454d-96bf-37c5af31a369 | 1 |
| 208813 | TobraDex (dexamethasone 0.1 % / tobramycin 0.3 % ) Ophthalmic Suspension | SY | 2a2259ee-05e4-4785-ba75-5946132debf3 | 1 |
| 208813 | TobraDex (dexamethasone 0.1 % / tobramycin 0.3 % ) Ophthalmic Suspension | SY | 330ac1f7-d583-454d-96bf-37c5af31a369 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0065-0647-05 | 00065064705 | 5 mL in 1 BOTTLE, PLASTIC (0065-0647-05) | 5 ml | 1988-09-15 | 0000-00-00 | No | No | Current |
| 0065-0647-10 | 00065064710 | 10 mL in 1 BOTTLE, PLASTIC (0065-0647-10) | 10 ml | 1988-09-15 | 0000-00-00 | No | No | Current |
| 0065-0647-25 | 00065064725 | 2.5 mL in 1 BOTTLE, PLASTIC (0065-0647-25) | 2.5 ml | 1988-09-15 | 0000-00-00 | No | No | Current |