TOBRAMYCIN
- Product NDC
- 61919-642
- 11-digit product format
- 619190642
- Labeler code
- 61919
- Product ID
- 61919-642_0e98b2f4-6caf-f58b-e063-6394a90ab0ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOBRAMYCIN
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- DirectRX
- Application
- ANDA207444
- Marketing category
- ANDA
- Marketing start
- 2019-04-23
- 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
- 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 |
|---|
| 61919-642-05 | TOBRAMYCIN | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-642 | TOBRAMYCIN SOLUTION TOBRAMYCIN SOLUTION/ DROPS [DIRECTRX] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240111_87349ae8-4709-7f5a-e053-2a91aa0ae3d1.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 |
|---|
| 61919-642-05 | 61919064205 | 5 mL in 1 BOTTLE (61919-642-05) | 5 ml | 2019-04-23 | 0000-00-00 | No | No | Current |