NDC 68788-6797

Ciclopirox

Ciclopirox

Ciclopirox is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Ciclopirox.

Product ID68788-6797_093fff4d-8827-49e2-8d41-37766587ea68
NDC68788-6797
Product TypeHuman Prescription Drug
Proprietary NameCiclopirox
Generic NameCiclopirox
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2016-11-03
Marketing CategoryANDA / ANDA
Application NumberANDA077623
Labeler NamePreferred Pharmaceuticals, Inc.
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 Through2023-12-31

Packaging

NDC 68788-6797-6

1 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-6797-6) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2016-11-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6797-6 [68788679706]

Ciclopirox SOLUTION
Marketing CategoryANDA
Application NumberANDA077623
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-03

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX80 mg/mL

OpenFDA Data

SPL SET ID:efcd78c0-2426-4fcc-a1c8-527e4e6f99d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309291
  • 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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