Tobramycin Ophthalmic Solution
- Product NDC
- 62332-518
- 11-digit product format
- 623320518
- Labeler code
- 62332
- Product ID
- 62332-518_5d11cea7-cb06-4ab9-930d-190549b2f4ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin Ophthalmic Solution
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA211847
- Marketing category
- ANDA
- Marketing start
- 2019-04-19
- Substance
- TOBRAMYCIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tobramycin Ophthalmic Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOBRAMYCIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 313415 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-518-05 | Tobramycin Ophthalmic Solution | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 9 |
| 62332-518-05 | Tobramycin Ophthalmic Solution | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-518 | TOBRAMYCIN OPHTHALMIC SOLUTION SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240616_3c23234a-452b-40d0-922f-37e49147d537.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 |
|---|
| 62332-518-05 | 62332051805 | 1 BOTTLE in 1 CARTON (62332-518-05) / 5 mL in 1 BOTTLE | 1 bottle | 2019-04-19 | 0000-00-00 | No | No | Current |