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 | 6213506635962135066359 | 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, LLCNDC labeler code 62135
- 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.
About NDC 62135-663
- What is NDC 62135-663?
- 62135-663 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tavaborole.
- What is the active ingredient?
- Tavaborole.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tavaborole?
- 6 other product NDCs are listed under this name. See all Tavaborole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tavaborole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Limited | 46708-467 | 46708-0467-0446708-0467-10 |
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Zydus Lifesciences Limited | 70771-1826 | 70771-1826-00 |
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Viona Pharmaceuticals Inc | 72578-102 | 72578-0102-04 |
| tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Mayne Pharma Commercial LLC | 51862-690 | — |
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Inc. | 62332-467 | 62332-0467-0462332-0467-10 |
| Tavaboroletavaborole topical solution, 5% | Tavaborole 43.5 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-020 | 21922-0020-12 |