Tobramycin
- Product NDC
- 80425-0341
- 11-digit product format
- 804250341
- Labeler code
- 80425
- Product ID
- 80425-0341_2862f6ad-689c-d683-e063-6394a90a89d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA064052
- Marketing category
- ANDA
- Marketing start
- 2023-05-24
- 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 |
|---|
| 80425-0341-1 | Tobramycin | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 80425-0341-1 | Tobramycin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0341 | TOBRAMYCIN SOLUTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 2 package rows | 20241207_fc734c2d-0d45-195c-e053-6394a90a2a92.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0341-1 | 80425034101 | 1 BOTTLE, DROPPER in 1 CARTON (80425-0341-1) / 5 mL in 1 BOTTLE, DROPPER | 2023-05-24 | No | No | Current |