Prescription drug · ANDA
Tobramycin NDC 80425-0341
Tobramycin 3 mg/mL · Solution · Ophthalmic · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0341-1 | 8042503410180425034101 | 1 BOTTLE, DROPPER in 1 CARTON (80425-0341-1) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 24, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0341_2862f6ad-689c-d683-e063-6394a90a89d1SPL ID 2862f6ad-689c-d683-e063-6394a90a89d1SPL set ID fc734c2d-0d45-195c-e053-6394a90a2a92RxCUI 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
N480425034101followed by a unit qualifier and the quantityPackage 80425-0341-01. 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.
About NDC 80425-0341
- What is NDC 80425-0341?
- 80425-0341 is the product NDC for Tobramycin, Tobramycin 3 mg/mL solution, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tobramycin.
- What is the active ingredient?
- Tobramycin.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tobramycin?
- 54 other product NDCs are listed under this name. See all Tobramycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tobramycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Preferred Pharmaceuticals Inc. | 68788-4149 | 68788-4149-05 |
| Tobramycin | Tobramycin 3 mg/mL | Solution/ dropsOphthalmic | JVET PHARMACEUTICALS LLC | 86211-110 | 86211-0110-01 |
| Tobramycin | Tobramycin 300 mg/5mL | SolutionRespiratory (Inhalation) | Ritedose Pharmaceuticals, LLC | 76204-029 | 76204-0029-56 |
| Tobramycin | Tobramycin 300 mg/5mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-430 | 72603-0430-56 |
| Tobramycin | Tobramycin 300 mg/4mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-630 | 72603-0630-56 |
| Tobramycin | Tobramycin 300 mg/5mL | SolutionRespiratory (Inhalation) | American Health Packaging | 60687-731 | 60687-0731-83 |
| Tobramycin | Tobramycin 3 mg/mL | Solution/ dropsOphthalmic | Belcher Pharmaceuticals, LLC | 62250-110 | 62250-0110-01 |
| Tobramycin | Tobramycin sulfate 1.2 g/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Northstar Rx LLC | 72603-160 | 72603-0160-06 |
| Tobramycintobramycin solution | Tobramycin 300 mg/5mL | InhalantRespiratory (Inhalation) | Micro Labs Limited | 42571-408 | 42571-0408-92 |
| Tobramycin | Tobramycin 300 mg/5mL | SolutionRespiratory (Inhalation) | Lifestar Pharma LLC | 70756-604 | 70756-0604-56 |
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 | A-S Medication Solutions | 50090-2127 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 63187-024 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 66267-936 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Preferred Pharmaceuticals Inc. | 68788-4149 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-791 |
| Tobramycin | Tobramycin 3 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-025 |