Prescription drug · ANDA
Tobramycin NDC 86211-110
Tobramycin 3 mg/mL · Solution/ drops · Ophthalmic · JVET PHARMACEUTICALS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 86211-110-01 | 86211011001 | 1 BOTTLE, PLASTIC in 1 CARTON (86211-110-01) / 5 mL in 1 BOTTLE, PLASTICMarketed from Jan 26, 2026 |
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/ drops
- Route
- Ophthalmic
- Labeler
- JVET PHARMACEUTICALS LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212628
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 86211-110_c6435b8f-bb6e-45e0-a52b-3087fd043b5aSPL ID c6435b8f-bb6e-45e0-a52b-3087fd043b5aSPL set ID c6435b8f-bb6e-45e0-a52b-3087fd043b5aRxCUI 313415UNII VZ8RRZ51VKUPC 0386211110012
- 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
N486211011001followed by a unit qualifier and the quantityPackage 86211-0110-01. 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 0.3%. 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 212628
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 | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-374 |
| Tobramycin | Tobramycin 3 mg/mL | Solution/ dropsOphthalmic | Belcher Pharmaceuticals, LLC | 62250-110 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.