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 ID: 10337-905_3d362b47-37c4-489d-91c6-a2b7ec99e207
• NDC: 10337-905
• Product Type: Human Prescription Drug
• Proprietary Name: Kerydin
• Generic Name: Tavaborole
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-07-07
• Marketing Category: NDA / NDA
• Application Number: NDA204427
• Labeler Name: PharmaDerm, A division of Fougera Pharmaceuticals Inc.
• Substance Name: TAVABOROLE
• Active Ingredient Strength: 44 mg/mL
• Pharm Classes: Oxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10337-905-10

1 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2014-07-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10337-905-44 [10337090544]

Kerydin SOLUTION

• Marketing Category: NDA
• Application Number: NDA204427
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-07-07

NDC 10337-905-10 [10337090510]

Kerydin SOLUTION

• Marketing Category: NDA
• Application Number: NDA204427
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-07-07

Drug Details

Active Ingredients

Ingredient	Strength
TAVABOROLE	43.5 mg/mL

OpenFDA Data

• SPL SET ID: 1ae61072-bca0-43f0-a741-07bda2d50c87
• Manufacturer:
  • PharmaDerm, A division of Fougera Pharmaceuticals Inc.
• UNII:
  • K124A4EUQ3
• 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"

NDC	Brand Name	Generic Name
10337-905	Kerydin	Tavaborole
0574-0157	Tavaborole	Tavaborole
51672-1397	TAVABOROLE	TAVABOROLE
51862-690	tavaborole	tavaborole
62332-467	Tavaborole	Tavaborole
63629-8704	Tavaborole	Tavaborole
68180-958	Tavaborole	Tavaborole
69097-686	TAVABOROLE	TAVABOROLE
69238-1657	Tavaborole	Tavaborole
71589-010	TAVABOROLE	TAVABOROLE
72763-201	Tavaborole	Tavaborole