Prescription drug · ANDA
Tavaborole (Tavaborole topical solution, 5%) NDC 21922-020
Tavaborole 43.5 mg/mL · Solution · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-020-12 | 2192200201221922002012 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) / 10 mL in 1 BOTTLE, WITH APPLICATORMarketed from Oct 19, 2020 |
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 topical solution, 5%
- Active ingredients
- Tavaborole — 43.5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- 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 21922-020_10a126f9-ec1b-44d2-8611-3d6660a53ae8SPL ID 10a126f9-ec1b-44d2-8611-3d6660a53ae8SPL set ID 050f5d10-5591-426e-9020-6516b3363304RxCUI 1543177UNII K124A4EUQ3
- 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
N421922002012followed by a unit qualifier and the quantityPackage 21922-0020-12. 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 mentagrophyte. 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 21922-020
- What is NDC 21922-020?
- 21922-020 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Encube Ethicals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tavaborole (TAVABOROLE topical solution, 5%).
- What is the active ingredient?
- Tavaborole.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 | Mayne Pharma Commercial LLC | 51862-690 | — |
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Inc. | 62332-467 | 62332-0467-0462332-0467-10 |
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 |
|---|---|---|---|---|
| tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Mayne Pharma Commercial LLC | 51862-690 |