NDC 99207-010

Loprox

Ciclopirox

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

Product ID99207-010_7f575fbc-73a9-4111-95cb-f40e0a2f4930
NDC99207-010
Product TypeHuman Prescription Drug
Proprietary NameLoprox
Generic NameCiclopirox
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date2003-03-20
Marketing CategoryNDA / NDA
Application NumberNDA021159
Labeler NameBausch Health US, LLC
Substance NameCICLOPIROX
Active Ingredient Strength10 mg/.96mL
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 99207-010-10

1 BOTTLE, PLASTIC in 1 CARTON (99207-010-10) > 120 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2003-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 99207-010-10 [99207001010]

Loprox SHAMPOO
Marketing CategoryNDA
Application NumberNDA021159
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-03-20

NDC 99207-010-01 [99207001001]

Loprox SHAMPOO
Marketing CategoryNDA
Application NumberNDA021159
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-03-20
Marketing End Date2018-03-02

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX10 mg/.96mL

OpenFDA Data

SPL SET ID:464a1be3-b72b-424d-b11b-a8f26126cce7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 544743
  • 250344
  • Pharmacological Class

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

    Medicade Reported Pricing

    99207001010 LOPROX 1% SHAMPOO

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    43538-540Loproxciclopirox olamine
    43538-541LoproxCiclopirox Olamine
    43538-550Loproxciclopirox olamine
    43538-551LoproxCiclopirox Olamine
    99207-010LoproxLoprox
    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
    0187-5180Penlacciclopirox

    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

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