What is NDC 72578-102?

72578-102 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tavaborole NDC 72578-102 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-102Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0102Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
72578-102-04	7257801020472578010204	1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-102-04) / 10 mL in 1 BOTTLE, WITH APPLICATORMarketed from Apr 24, 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: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212294
Marketing start: Apr 24, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Boron Compounds (Chemical structure)Protein Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 72578-102_266f7bbc-b540-4681-8144-cbb823f34f0eSPL ID 266f7bbc-b540-4681-8144-cbb823f34f0eSPL set ID c13610c8-c57a-4519-b37d-eb4fbdcec398RxCUI 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

N472578010204 followed by a unit qualifier and the quantity

Package 72578-0102-04. 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 Dec 6, 2024.

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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-102

What is NDC 72578-102?: 72578-102 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Viona Pharmaceuticals Inc. 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?: Viona Pharmaceuticals Inc, NDC labeler code 72578. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tavaborole NDCs
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	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 212294

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212294
Product	Strength	Form · route	Labeler	Product NDC
Tavaborole	Tavaborole 43.5 mg/mL	SolutionTopical	Zydus Lifesciences Limited	70771-1826