Prescription drug · ANDA
Tobramycin Ophthalmic Solution NDC 46708-518
Tobramycin 3 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-518-05 | 46708051805 | 1 BOTTLE in 1 CARTON (46708-518-05) / 5 mL in 1 BOTTLEMarketed from Apr 19, 2019 |
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 Ophthalmic Solution
- Generic name (nonproprietary)
- tobramycin ophthalmic solution
- Active ingredients
- Tobramycin — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211847
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 46708-518_14c14f81-6b0a-4176-a5df-d0757cc3260dSPL ID 14c14f81-6b0a-4176-a5df-d0757cc3260dSPL set ID 14c14f81-6b0a-4176-a5df-d0757cc3260dRxCUI 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
N446708051805followed by a unit qualifier and the quantityPackage 46708-0518-05. 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 211847
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 Ophthalmic Solution | Tobramycin 3 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-518 |