NDC 0168-0522

Ciclopirox

Ciclopirox

Ciclopirox is a Topical Shampoo in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Ciclopirox.

Product ID0168-0522_9888b9d1-09b5-4fe0-a27b-6f7672c5f66c
NDC0168-0522
Product TypeHuman Prescription Drug
Proprietary NameCiclopirox
Generic NameCiclopirox
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date2012-11-19
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021159
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameCICLOPIROX
Active Ingredient Strength10 mg/.96mL
Pharm ClassesDecreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0168-0522-04

1 BOTTLE, PLASTIC in 1 CARTON (0168-0522-04) > 120 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2012-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0522-04 [00168052204]

Ciclopirox SHAMPOO
Marketing CategoryNDA authorized generic
Application NumberNDA021159
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-11-19

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX10 mg/.96mL

OpenFDA Data

SPL SET ID:3c1c9e90-1f65-4d30-8163-44844f8b3f36
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]

    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

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