NDC 0574-2061

CICLOPIROX

Ciclopirox

CICLOPIROX is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Paddock Laboratories, Llc. The primary component is Ciclopirox.

Product ID0574-2061_47417670-39e7-4c06-8638-cb8984aed47e
NDC0574-2061
Product TypeHuman Prescription Drug
Proprietary NameCICLOPIROX
Generic NameCiclopirox
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2009-01-07
Marketing CategoryANDA / ANDA
Application NumberANDA078266
Labeler NamePaddock Laboratories, LLC
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 0574-2061-01

1 TUBE in 1 CARTON (0574-2061-01) > 100 g in 1 TUBE
Marketing Start Date2009-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0574-2061-01 [00574206101]

CICLOPIROX GEL
Marketing CategoryANDA
Application NumberANDA078266
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2009-01-07

NDC 0574-2061-45 [00574206145]

CICLOPIROX GEL
Marketing CategoryANDA
Application NumberANDA078266
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2009-01-07

NDC 0574-2061-30 [00574206130]

CICLOPIROX GEL
Marketing CategoryANDA
Application NumberANDA078266
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2009-01-07

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX7.7 mg/g

OpenFDA Data

SPL SET ID:b6a02568-867b-4c7b-890f-5d28bf0b363d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313941

    • 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 "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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