Prescription drug · ANDA
Tobramycin NDC 76420-791
Tobramycin 3 mg/mL · Solution · Ophthalmic · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-791-05 | 76420079105 | 1 BOTTLE, DROPPER in 1 CARTON (76420-791-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 20, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tobramycin
- Generic name (nonproprietary)
- tobramycin
- Active ingredients
- Tobramycin — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064052
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 76420-791_14111f01-7d9a-6602-e063-6294a90a47a8SPL ID 14111f01-7d9a-6602-e063-6294a90a47a8SPL set ID c6f9c6b1-2c45-4f6b-a1fb-e55d74fc04c3RxCUI 313415UNII VZ8RRZ51VK
- Pharmacologic class
- Aminoglycoside Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476420079105followed by a unit qualifier and the quantityPackage 76420-0791-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Tobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 064052
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-290 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 66267-936 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-025 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-2127 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 63187-024 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0341 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Preferred Pharmaceuticals Inc. | 68788-4149 |