TOBRAMYCIN AND DEXAMETHASONE
- Product NDC
- 72162-1128
- 11-digit product format
- 721621128
- Labeler code
- 72162
- Product ID
- 72162-1128_432e0889-d4ff-4486-a295-7ff4004904bb
- 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
- 2027-12-31
- 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 |
|---|
| 72162-1128-2 | TOBRAMYCIN AND DEXAMETHASONE | 10 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 10 | | 102 |
| 72162-1128-4 | TOBRAMYCIN AND DEXAMETHASONE | 5 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 5 | | 102 |
| 72162-1128-7 | TOBRAMYCIN AND DEXAMETHASONE | 2.5 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 2.5 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-1128 | TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BRYANT RANCH PREPACK] | 100 | Current NDC, 3 package rows | 20241228_df4a7747-8dfa-4933-b4d2-a3d85c5f74f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-1128-2 | 72162112802 | 10 mL in 1 BOTTLE, PLASTIC (72162-1128-2) | 10 ml | 2024-12-24 | No | No | Historical |
| 72162-1128-4 | 72162112804 | 5 mL in 1 BOTTLE, PLASTIC (72162-1128-4) | 5 ml | 2024-12-24 | No | No | Historical |
| 72162-1128-7 | 72162112807 | 2.5 mL in 1 BOTTLE, PLASTIC (72162-1128-7) | 2.5 ml | 2024-12-24 | No | No | Historical |