Prescription drug · ANDA
Tavaborole NDC 62135-663
Tavaborole 43.5 mg/mL · Solution · Topical · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-663-59 | 62135066359 | 10 mL in 1 BOTTLE, DROPPER (62135-663-59)Marketed from Sep 8, 2023 |
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
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211963
- Marketing start
- Listing expires
- Other FDA classes
- Boron Compounds (Chemical structure)Protein Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-663_056ba459-06c7-c5c1-e063-6394a90a54bcSPL ID 056ba459-06c7-c5c1-e063-6394a90a54bcSPL set ID 7fe75d38-80a0-444e-84bc-4087b45a791eRxCUI 1543177UNII K124A4EUQ3UPC 0362135663599
- 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
N462135066359followed by a unit qualifier and the quantityPackage 62135-0663-59. 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 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 . ( 1 )
Excerpt only. Read the full label for complete information.