NDC 45802-401

Ciclopirox

Ciclopirox

Ciclopirox is a Topical Shampoo in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Ciclopirox.

Product ID45802-401_4483da8b-c5a0-47e9-a9b8-c9ebdf98fd39
NDC45802-401
Product TypeHuman Prescription Drug
Proprietary NameCiclopirox
Generic NameCiclopirox
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date2010-02-17
Marketing CategoryANDA / ANDA
Application NumberANDA078594
Labeler NamePadagis Israel Pharmaceuticals Ltd
Substance NameCICLOPIROX
Active Ingredient Strength1 g/100mL
Pharm ClassesDecreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 45802-401-09

120 mL in 1 BOTTLE (45802-401-09)
Marketing Start Date2010-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45802-401-09 [45802040109]

Ciclopirox SHAMPOO
Marketing CategoryANDA
Application NumberANDA078594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-02-17

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX1 g/100mL

OpenFDA Data

SPL SET ID:c3722d52-407c-499b-a08b-b299609f203c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 250344
  • Pharmacological Class

    • Decreased DNA Replication [PE]
    • Decreased Protein Synthesis [PE]
    • Decreased RNA Replication [PE]
    • Protein Synthesis Inhibitors [MoA]
    • Decreased DNA Replication [PE]
    • Decreased Protein Synthesis [PE]
    • Decreased RNA Replication [PE]
    • Protein Synthesis Inhibitors [MoA]

    Medicade Reported Pricing

    45802040109 CICLOPIROX 1% SHAMPOO

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Ciclopirox" or generic name "Ciclopirox"

    NDCBrand NameGeneric Name
    0168-0314Ciclopiroxciclopirox
    0168-0407CiclopiroxCiclopirox
    0168-0449CiclopiroxCiclopirox
    0168-0522Ciclopiroxciclopirox
    0574-2061CICLOPIROXCICLOPIROX
    0591-2159CiclopiroxCiclopirox
    0713-0317CiclopiroxCICLOPIROX
    21695-475CiclopiroxCiclopirox
    42192-714CiclopiroxCiclopirox
    42192-715CiclopiroxCiclopirox
    45802-141CiclopiroxCiclopirox
    45802-401CiclopiroxCiclopirox
    47781-530CiclopiroxCiclopirox
    50383-419CiclopiroxCiclopirox
    51672-1323CiclopiroxCiclopirox
    51672-1351Ciclopiroxciclopirox
    51672-5302Ciclopiroxciclopirox
    52565-032Ciclopiroxciclopirox
    61360-1351Ciclopiroxciclopirox
    61748-200CICLOPIROXCICLOPIROX
    63629-8620CICLOPIROXCICLOPIROX
    68071-1524CiclopiroxCiclopirox
    68071-4412CiclopiroxCiclopirox
    68462-455ciclopiroxciclopirox
    68788-6797CiclopiroxCiclopirox
    68788-7138CiclopiroxCiclopirox
    68071-4977CiclopiroxCiclopirox
    43538-500Ciclodanciclopirox
    43538-501Ciclodanciclopirox
    0187-5180Penlacciclopirox

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.