NDC 0168-0449

Ciclopirox

Ciclopirox

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

Product ID0168-0449_710704bb-c966-436e-962e-1c317c27269f
NDC0168-0449
Product TypeHuman Prescription Drug
Proprietary NameCiclopirox
Generic NameCiclopirox
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date2010-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA090146
Labeler NameFougera 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 Through2021-12-31

Packaging

NDC 0168-0449-04

1 BOTTLE in 1 CARTON (0168-0449-04) > 120 mL in 1 BOTTLE
Marketing Start Date2010-05-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0449-04 [00168044904]

Ciclopirox SHAMPOO
Marketing CategoryANDA
Application NumberANDA090146
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX10 mg/.96mL

OpenFDA Data

SPL SET ID:288a1cb0-ff4c-482c-9f1a-45ea3dbb3b52
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 250344
  • UPC Code
  • 0301680449043
  • Pharmacological Class

    • 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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