NDC codes

FDA NDC Directory
Product NDC (as listed)62135-663Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0663Add 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 NDC11-digit (billing)PackageCopy
62135-663-59621350663596213506635910 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

N462135066359 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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

Other Tavaborole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalAlembic Pharmaceuticals Limited46708-46746708-0467-0446708-0467-10
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalZydus Lifesciences Limited70771-182670771-1826-00
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalViona Pharmaceuticals Inc72578-10272578-0102-04
tavaboroleTavaborole 43.5 mg/mLSolutionTopicalMayne Pharma Commercial LLC51862-690—
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalAlembic Pharmaceuticals Inc.62332-46762332-0467-0462332-0467-10
Tavaboroletavaborole topical solution, 5%Tavaborole 43.5 mg/mLSolutionTopicalEncube Ethicals, Inc.21922-02021922-0020-12

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