Tobramycin
- Product NDC
- 76420-791
- 11-digit product format
- 764200791
- Labeler code
- 76420
- Product ID
- 76420-791_14111f01-7d9a-6602-e063-6294a90a47a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA064052
- Marketing category
- ANDA
- Marketing start
- 1993-11-29
- 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 |
|---|
| 76420-791-05 | Tobramycin | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 76420-791-05 | Tobramycin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-791 | TOBRAMYCIN SOLUTION [ASCLEMED USA, INC.] | 1 | Current NDC, 2 package rows | 20240321_c6f9c6b1-2c45-4f6b-a1fb-e55d74fc04c3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-791-05 | 76420079105 | 1 BOTTLE, DROPPER in 1 CARTON (76420-791-05) / 5 mL in 1 BOTTLE, DROPPER | 2024-03-20 | No | No | Current |