Tobramycin
- Product NDC
- 65162-914
- 11-digit product format
- 651620914
- Labeler code
- 65162
- Product ID
- 65162-914_609a53df-fb3c-4349-8ada-22b985d2c4ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205501
- Marketing category
- ANDA
- Marketing start
- 2014-07-13
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/5mL
- 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 | 300 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 348719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-914-46 | Tobramycin | 56 in 1 CARTON | SOLUTION | 56 | | 24 |
| 65162-914-46 | Tobramycin | 5 mL in 1 AMPULE | SOLUTION | 5 | | 24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-914 | TOBRAMYCIN SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 24 | Current NDC, Legacy NDC, 2 package rows | 20241031_15f9c0cd-7dbf-4a91-9961-14f1dd000343.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 |
|---|
| 65162-914-46 | 65162091446 | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE | 56 ampule | 2014-07-13 | 0000-00-00 | No | No | Current |