NDC 68462-455

ciclopirox

Ciclopirox

ciclopirox is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Ciclopirox.

Product ID68462-455_f4188436-4d86-48c2-89a9-7c73862bb8fe
NDC68462-455
Product TypeHuman Prescription Drug
Proprietary Nameciclopirox
Generic NameCiclopirox
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2012-02-29
Marketing CategoryANDA / ANDA
Application NumberANDA091595
Labeler NameGlenmark Pharmaceuticals Inc., USA
Substance NameCICLOPIROX
Active Ingredient Strength8 mg/g
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 68462-455-35

30 g in 1 TUBE (68462-455-35)
Marketing Start Date2012-02-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-455-47 [68462045547]

ciclopirox GEL
Marketing CategoryANDA
Application NumberANDA091595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2012-02-29

NDC 68462-455-35 [68462045535]

ciclopirox GEL
Marketing CategoryANDA
Application NumberANDA091595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2012-02-29

NDC 68462-455-94 [68462045594]

ciclopirox GEL
Marketing CategoryANDA
Application NumberANDA091595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2012-02-29

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX7.7 mg/g

OpenFDA Data

SPL SET ID:3c22416e-4293-4ba5-a983-137cbc6022db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313941
  • UPC Code
  • 0368462455470
  • 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]

    Medicade Reported Pricing

    68462045594 CICLOPIROX 0.77% GEL

    Pricing Unit: GM | Drug Type:

    68462045547 CICLOPIROX 0.77% GEL

    Pricing Unit: GM | Drug Type:

    68462045535 CICLOPIROX 0.77% GEL

    Pricing Unit: GM | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.