TobraDex
- Product NDC
- 21695-203
- 11-digit product format
- 216950203
- Labeler code
- 21695
- Product ID
- 21695-203_330ac1f7-d583-454d-96bf-37c5af31a369
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin and dexamethasone
- Dosage form
- SUSPENSION
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- NDA050592
- Marketing category
- NDA
- Marketing start
- 1988-08-18
- Marketing end
- 0000-00-00
- Substance
- TOBRAMYCIN; DEXAMETHASONE
- Active strength
- 3 mg/mL; mg/mL
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-203-05 | TobraDex | 5 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 5 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-203 | TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110104_330ac1f7-d583-454d-96bf-37c5af31a369.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 21695-203-05 | 21695020305 | 5 mL in 1 BOTTLE, PLASTIC | 5 ml | Historical |