Tobramycin Ophthalmic Solution
- Product NDC
- 46708-518
- 11-digit product format
- 467080518
- Labeler code
- 46708
- Product ID
- 46708-518_14c14f81-6b0a-4176-a5df-d0757cc3260d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin Ophthalmic Solution
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Limited
- 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 |
|---|
| 46708-518-05 | Tobramycin Ophthalmic Solution | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
| 46708-518-05 | Tobramycin Ophthalmic Solution | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-518 | TOBRAMYCIN OPHTHALMIC SOLUTION SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20240616_14c14f81-6b0a-4176-a5df-d0757cc3260d.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 |
|---|
| 46708-518-05 | 46708051805 | 1 BOTTLE in 1 CARTON (46708-518-05) / 5 mL in 1 BOTTLE | 1 bottle | 2019-04-19 | No | No | Historical |