Prescription drug · ANDA
Tobramycin NDC 63187-024
Tobramycin 3 mg/mL · Solution · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-024-05 | 63187002405 | 1 BOTTLE, DROPPER in 1 CARTON (63187-024-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2018 |
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
- Proficient Rx LP
- 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 63187-024_6458f461-e408-4dcc-b7c3-f8fb9fbcb31dSPL ID 6458f461-e408-4dcc-b7c3-f8fb9fbcb31dSPL set ID d8235017-cb52-44d4-a6e6-6ee3f00c47d2RxCUI 313415UNII VZ8RRZ51VKUPC 0363187024055
- 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
N463187002405followed by a unit qualifier and the quantityPackage 63187-0024-05. 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 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 | Asclemed USA, Inc. | 76420-791 |
| 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 |