TOBRAMYCIN AND DEXAMETHASONE
- Product NDC
- 63629-9572
- 11-digit product format
- 636299572
- Labeler code
- 63629
- Product ID
- 63629-9572_ab233ed9-6d75-4ff3-82fe-c6872fc8a839
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin and dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212715
- Marketing category
- ANDA
- Marketing start
- 2022-03-17
- Substance
- DEXAMETHASONE; TOBRAMYCIN
- Active strength
- 1; 3 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOBRAMYCIN AND DEXAMETHASONE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 1 mg/mL |
| TOBRAMYCIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, VZ8RRZ51VK |
| Rxcui | 309683 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-9572-1 | TOBRAMYCIN AND DEXAMETHASONE | 10 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 10 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9572 | TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 1 package rows | 20240113_1884ef6f-a60c-4a82-a7dc-fd48b7176db0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-9572-1 | 63629957201 | 10 mL in 1 BOTTLE, PLASTIC (63629-9572-1) | 10 ml | 2022-12-21 | 0000-00-00 | No | No | Current |