NDC 10337-905

Kerydin

Tavaborole

Kerydin is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.. The primary component is Tavaborole.

Product ID10337-905_3d362b47-37c4-489d-91c6-a2b7ec99e207
NDC10337-905
Product TypeHuman Prescription Drug
Proprietary NameKerydin
Generic NameTavaborole
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2014-07-07
Marketing CategoryNDA / NDA
Application NumberNDA204427
Labeler NamePharmaDerm, A division of Fougera Pharmaceuticals Inc.
Substance NameTAVABOROLE
Active Ingredient Strength44 mg/mL
Pharm ClassesOxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10337-905-10

1 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2014-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10337-905-44 [10337090544]

Kerydin SOLUTION
Marketing CategoryNDA
Application NumberNDA204427
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-07-07

NDC 10337-905-10 [10337090510]

Kerydin SOLUTION
Marketing CategoryNDA
Application NumberNDA204427
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-07-07

Drug Details

Active Ingredients

IngredientStrength
TAVABOROLE43.5 mg/mL

OpenFDA Data

SPL SET ID:1ae61072-bca0-43f0-a741-07bda2d50c87
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1543177
  • 1543182
  • Pharmacological Class

    • Oxaborole Antifungal [EPC]
    • Protein Synthesis Inhibitors [MoA]
    • Boron Compounds [CS]
    • Oxaborole Antifungal [EPC]
    • Protein Synthesis Inhibitors [MoA]
    • Boron Compounds [CS]

    Medicade Reported Pricing

    10337090544 KERYDIN 5% TOPICAL SOLUTION

    Pricing Unit: ML | Drug Type:

    10337090510 KERYDIN 5% TOPICAL SOLUTION

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Kerydin" or generic name "Tavaborole"

    NDCBrand NameGeneric Name
    10337-905KerydinTavaborole
    0574-0157TavaboroleTavaborole
    51672-1397TAVABOROLETAVABOROLE
    51862-690tavaboroletavaborole
    62332-467TavaboroleTavaborole
    63629-8704TavaboroleTavaborole
    68180-958TavaboroleTavaborole
    69097-686TAVABOROLETAVABOROLE
    69238-1657TavaboroleTavaborole
    71589-010TAVABOROLETAVABOROLE
    72763-201TavaboroleTavaborole

    Trademark Results [Kerydin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KERYDIN
    KERYDIN
    86281630 4796355 Live/Registered
    Anacor Pharmaceuticals, Inc.
    2014-05-14
    KERYDIN
    KERYDIN
    85672220 4653277 Live/Registered
    Anacor Pharmaceuticals, Inc.
    2012-07-09

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