NDC 43538-550

Loprox

Ciclopirox Olamine

Loprox is a Topical Suspension in the Human Prescription Drug category. It is labeled and distributed by Medimetriks Pharmaceuticals, Inc.. The primary component is Ciclopirox Olamine.

Product ID43538-550_0efc4273-be47-4751-98f8-626f3fb85754
NDC43538-550
Product TypeHuman Prescription Drug
Proprietary NameLoprox
Generic NameCiclopirox Olamine
Dosage FormSuspension
Route of AdministrationTOPICAL
Marketing Start Date2016-10-14
Marketing CategoryNDA / NDA
Application NumberNDA019824
Labeler NameMedimetriks 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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43538-550-60

1 BOTTLE in 1 CARTON (43538-550-60) > 60 mL in 1 BOTTLE
Marketing Start Date2016-10-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43538-550-60 [43538055060]

Loprox SUSPENSION
Marketing CategoryNDA
Application NumberNDA019824
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-14

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX OLAMINE7.7 mg/mL

OpenFDA Data

SPL SET ID:befa91b7-ea2b-4fbb-9e4c-45993bfd7c18
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309290
  • 351383

    • 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 "Loprox" or generic name "Ciclopirox Olamine"

    NDCBrand NameGeneric Name
    43538-540Loproxciclopirox olamine
    43538-541LoproxCiclopirox Olamine
    43538-550Loproxciclopirox olamine
    43538-551LoproxCiclopirox Olamine
    99207-010Loproxciclopirox
    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

    Trademark Results [Loprox]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LOPROX
    LOPROX
    85380415 4108759 Live/Registered
    Medicis Pharmaceutical Corporation
    2011-07-25
    LOPROX
    LOPROX
    74123436 not registered Dead/Abandoned
    Bayer Aktiengesellschuft
    1990-12-14
    LOPROX
    LOPROX
    73304454 1221402 Live/Registered
    Hoechst Aktiengesellschaft
    1981-04-06
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