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 | 4670804670446708046704 | 1 BOTTLE, DROPPER in 1 CARTON (46708-467-04) / 4 mL in 1 BOTTLE, DROPPERMarketed from Feb 18, 2025 | |
| 46708-467-10 | 4670804671046708046710 | 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
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- 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.
About NDC 46708-467
- What is NDC 46708-467?
- 46708-467 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 | 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 | 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 |
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 |