Prescription drug · ANDA
Tavaborole NDC 46708-467
Tavaborole 43.5 mg/mL · Solution · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-467-04 | 46708046704 | 1 BOTTLE, DROPPER in 1 CARTON (46708-467-04) / 4 mL in 1 BOTTLE, DROPPERMarketed from Feb 18, 2025 | |
| 46708-467-10 | 46708046710 | 1 BOTTLE, DROPPER in 1 CARTON (46708-467-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Feb 18, 2025 |
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)
- Tavaborole
- Generic name (nonproprietary)
- tavaborole
- Active ingredients
- Tavaborole — 43.5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212188
- Marketing start
- Listing expires
- Other FDA classes
- Boron Compounds (Chemical structure)Protein Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-467_0bf82467-4605-43ba-a217-cdba1946becdSPL ID 0bf82467-4605-43ba-a217-cdba1946becdSPL set ID 6da415c6-a9be-42bf-829f-e72ccc5fe3baRxCUI 1543177UNII K124A4EUQ3UPC 0346708467104
- Pharmacologic class
- Oxaborole Antifungal
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N446708046704followed by a unit qualifier and the quantityPackage 46708-0467-04. 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)
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212188
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 |
|---|---|---|---|---|
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Inc. | 62332-467 |