NDC codes

FDA NDC Directory
Product NDC (as listed)62332-467Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0467Add 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
62332-467-0462332046704623320467041 BOTTLE, DROPPER in 1 CARTON (62332-467-04) / 4 mL in 1 BOTTLE, DROPPERMarketed from Oct 23, 2020
62332-467-1062332046710623320467101 BOTTLE, DROPPER in 1 CARTON (62332-467-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 23, 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
Active ingredients
Tavaborole — 43.5 mg/mL
Dosage form
Solution
Route
Topical
Labeler
Alembic Pharmaceuticals Inc.NDC labeler code 62332
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 62332-467_d35e58d2-869d-40bf-a00e-296a9d3bb659SPL ID d35e58d2-869d-40bf-a00e-296a9d3bb659SPL set ID 22a6617b-d4b1-405e-901a-0b39a7b2837dRxCUI 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

N462332046704 followed by a unit qualifier and the quantity

Package 62332-0467-04. 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.

Full label on DailyMed (opens in a new tab)

About NDC 62332-467

What is NDC 62332-467?
62332-467 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Alembic Pharmaceuticals Inc.. 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 Inc., NDC labeler code 62332. 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/mLSolutionTopicalChartwell RX, LLC62135-66362135-0663-59
tavaboroleTavaborole 43.5 mg/mLSolutionTopicalMayne Pharma Commercial LLC51862-690—
Tavaboroletavaborole topical solution, 5%Tavaborole 43.5 mg/mLSolutionTopicalEncube Ethicals, Inc.21922-02021922-0020-12

Other NDCs under ANDA 212188

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

FDA NDC Directory listings under ANDA 212188
ProductStrengthForm · routeLabelerProduct NDC
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalAlembic Pharmaceuticals Limited46708-467

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