NDC 0187-5180

Penlac

Ciclopirox

Penlac is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Ciclopirox.

Product ID0187-5180_50c70e79-72ba-4581-9b50-c710e446bb0a
NDC0187-5180
Product TypeHuman Prescription Drug
Proprietary NamePenlac
Generic NameCiclopirox
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2013-05-01
Marketing CategoryNDA / NDA
Application NumberNDA021022
Labeler NameBausch Health US LLC
Substance NameCICLOPIROX
Active Ingredient Strength80 mg/mL
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 0187-5180-06

6.6 mL in 1 BOTTLE, WITH APPLICATOR (0187-5180-06)
Marketing Start Date2013-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-5180-06 [00187518006]

Penlac SOLUTION
Marketing CategoryNDA
Application NumberNDA021022
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-05-01

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX80 mg/mL

OpenFDA Data

SPL SET ID:9793245c-c3e0-4351-a2ab-b54b46aecb43
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309291
  • 261345
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Penlac" or generic name "Ciclopirox"

    NDCBrand NameGeneric Name
    0187-5180Penlacciclopirox
    43538-500Ciclodanciclopirox
    43538-501Ciclodanciclopirox
    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

    Trademark Results [Penlac]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PENLAC
    PENLAC
    98438627 not registered Live/Pending
    Pharma 101, LLC
    2024-03-07
    PENLAC
    PENLAC
    78147034 2740467 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2002-07-24
    PENLAC
    PENLAC
    75879757 not registered Dead/Abandoned
    Dermik Laboratories, Inc.
    1999-12-23
    PENLAC
    PENLAC
    75833341 not registered Dead/Abandoned
    HOECHST MARION ROUSSEL, INC.
    1999-10-27

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