NDC 72934-4045

CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%

Ciclopirox 8% / Fluconazole 1% / Terbinafine Hcl 1%

CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Ciclopirox; Fluconazole; Terbinafine.

Product ID72934-4045_87480bb9-e7a8-5ef1-e053-2995a90a0e40
NDC72934-4045
Product TypeHuman Prescription Drug
Proprietary NameCICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%
Generic NameCiclopirox 8% / Fluconazole 1% / Terbinafine Hcl 1%
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2019-05-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameSincerus Florida, LLC
Substance NameCICLOPIROX; FLUCONAZOLE; TERBINAFINE
Active Ingredient Strength8 g/100g; g/100g; g/100g
Pharm ClassesDecreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA],Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Allylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72934-4045-9

15 g in 1 VIAL, GLASS (72934-4045-9)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72934-4045-9 [72934404509]

CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX8 g/100g

Pharmacological Class

  • Decreased DNA Replication [PE]
  • Decreased Protein Synthesis [PE]
  • Decreased RNA Replication [PE]
  • Protein Synthesis Inhibitors [MoA]
  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Allylamine [CS]
  • Allylamine Antifungal [EPC]
  • Decreased DNA Replication [PE]
  • Decreased Protein Synthesis [PE]
  • Decreased RNA Replication [PE]
  • Protein Synthesis Inhibitors [MoA]
  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Allylamine [CS]
  • Allylamine Antifungal [EPC]

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