Prescription drug · ANDA
tavaborole NDC 51862-690
Tavaborole 43.5 mg/mL · Solution · Topical · Mayne Pharma Commercial LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- tavaborole
- Generic name (nonproprietary)
- tavaborole
- Active ingredients
- Tavaborole — 43.5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Mayne Pharma Commercial LLCNDC labeler code 51862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211297
- Marketing start
- Listing expires
- Other FDA classes
- Boron Compounds (Chemical structure)Protein Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 51862-690_12ed0433-3ec5-f721-e063-6294a90adc2bSPL ID 12ed0433-3ec5-f721-e063-6294a90adc2bSPL set ID 7ad9dc39-7501-4db5-a935-d9be8eea30a6RxCUI 1543177UNII K124A4EUQ3UPC 0351862690107
- 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.
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 . ( 1 ) ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 51862-690
- What is NDC 51862-690?
- 51862-690 is the product NDC for tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Mayne Pharma Commercial LLC.
- What drug is associated with this NDC?
- tavaborole.
- What is the active ingredient?
- Tavaborole.
- Who is the labeler?
- Mayne Pharma Commercial LLC, NDC labeler code 51862. 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 | Chartwell RX, LLC | 62135-663 | 62135-0663-59 |
| 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 |
Other NDCs under ANDA 211297
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 |
|---|---|---|---|---|
| Tavaboroletavaborole topical solution, 5% | Tavaborole 43.5 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-020 |