NDC 0168-0313

ciclopirox olamine

Ciclopirox Olamine

ciclopirox olamine is a Topical Cream 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 ID0168-0313_2c9efbd4-8a94-4331-b8b3-271d3036e2ff
NDC0168-0313
Product TypeHuman Prescription Drug
Proprietary Nameciclopirox olamine
Generic NameCiclopirox Olamine
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2004-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA076435
Labeler NameE. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.
Substance NameCICLOPIROX OLAMINE
Active Ingredient Strength8 mg/g
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 0168-0313-90

1 TUBE in 1 CARTON (0168-0313-90) > 90 g in 1 TUBE
Marketing Start Date2004-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0313-15 [00168031315]

ciclopirox olamine CREAM
Marketing CategoryANDA
Application NumberANDA076435
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-29
Marketing End Date2012-11-30

NDC 0168-0313-90 [00168031390]

ciclopirox olamine CREAM
Marketing CategoryANDA
Application NumberANDA076435
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-29
Marketing End Date2012-11-30

NDC 0168-0313-30 [00168031330]

ciclopirox olamine CREAM
Marketing CategoryANDA
Application NumberANDA076435
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-29
Marketing End Date2012-09-30

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX OLAMINE7.7 mg/g

OpenFDA Data

SPL SET ID:8bb9fcdf-c0f2-49f5-b5fc-6f4f98581c6a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309289
  • Pharmacological Class

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

    NDC Crossover Matching brand name "ciclopirox olamine" or generic name "Ciclopirox Olamine"

    NDCBrand NameGeneric Name
    0168-0313ciclopirox olamineciclopirox olamine
    0713-0638Ciclopirox OlamineCiclopirox Olamine
    45802-138Ciclopirox OlamineCiclopirox Olamine
    45802-400Ciclopirox OlamineCiclopirox Olamine
    49999-646CICLOPIROX OLAMINECICLOPIROX OLAMINE
    51672-1318Ciclopirox Olamineciclopirox olamine
    53002-9450Ciclopirox Olamineciclopirox olamine
    63629-2522Ciclopirox OlamineCiclopirox Olamine
    63629-8624Ciclopirox OlamineCiclopirox Olamine
    63629-8625Ciclopirox OlamineCiclopirox Olamine
    63629-8626Ciclopirox OlamineCiclopirox Olamine
    63629-8627Ciclopirox OlamineCiclopirox Olamine
    68071-1608Ciclopirox OlamineCiclopirox Olamine
    68071-4162Ciclopirox Olamineciclopirox olamine
    68258-3996Ciclopirox OlamineCiclopirox Olamine
    68462-297Ciclopirox OlamineCiclopirox Olamine
    69315-309CICLOPIROX OLAMINECICLOPIROX OLAMINE
    80425-0225Ciclopirox OlamineCiclopirox Olamine
    43538-540Loproxciclopirox olamine
    43538-541LoproxCiclopirox Olamine
    43538-550Loproxciclopirox olamine
    43538-551LoproxCiclopirox Olamine

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