NDC 0168-0314

Ciclopirox

Ciclopirox

Ciclopirox is a Topical Lotion 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 Olamine.

Product ID0168-0314_ae069f7e-d070-401d-8d1b-3e835d9f48c8
NDC0168-0314
Product TypeHuman Prescription Drug
Proprietary NameCiclopirox
Generic NameCiclopirox
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2004-08-06
Marketing CategoryANDA / ANDA
Application NumberANDA076422
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameCICLOPIROX OLAMINE
Active Ingredient Strength8 mg/mL
Pharm ClassesDecreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0168-0314-30

30 mL in 1 BOTTLE (0168-0314-30)
Marketing Start Date2004-08-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0314-60 [00168031460]

Ciclopirox LOTION
Marketing CategoryANDA
Application NumberANDA076422
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-08-06
Inactivation Date2020-01-31

NDC 0168-0314-30 [00168031430]

Ciclopirox LOTION
Marketing CategoryANDA
Application NumberANDA076422
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-08-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX OLAMINE7.7 mg/mL

OpenFDA Data

SPL SET ID:4aeae21c-8c03-4fa9-a191-6b1e9000cbdb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309290
  • UPC Code
  • 0301680314303
  • 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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