NDC 99207-276

Zyclara

Imiquimod

Zyclara is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Imiquimod.

Product ID99207-276_189de06b-1e8e-422e-9098-250834457c06
NDC99207-276
Product TypeHuman Prescription Drug
Proprietary NameZyclara
Generic NameImiquimod
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2012-02-29
Marketing CategoryNDA / NDA
Application NumberNDA022483
Labeler NameBausch Health US, LLC
Substance NameIMIQUIMOD
Active Ingredient Strength3 mg/g
Pharm ClassesIncreased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 99207-276-01

1 BOTTLE, PUMP in 1 CARTON (99207-276-01) > 7.5 g in 1 BOTTLE, PUMP
Marketing Start Date2012-02-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 99207-276-01 [99207027601]

Zyclara CREAM
Marketing CategoryNDA
Application NumberNDA022483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29

NDC 99207-276-75 [99207027675]

Zyclara CREAM
Marketing CategoryNDA
Application NumberNDA022483
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2012-02-29

NDC 99207-276-15 [99207027615]

Zyclara CREAM
Marketing CategoryNDA
Application NumberNDA022483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29
Marketing End Date2014-11-11

Drug Details

Active Ingredients

IngredientStrength
IMIQUIMOD2.5 mg/g

OpenFDA Data

SPL SET ID:28cd9b5b-680b-480f-b33d-9c5b52bbf03d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248440
  • 967021
  • 967017
  • 1248442
  • Pharmacological Class

    • Increased Cytokine Activity [PE]
    • Increased Cytokine Production [PE]
    • Interferon Inducers [MoA]

    Medicade Reported Pricing

    99207027675 ZYCLARA 2.5% CREAM PUMP

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Zyclara" or generic name "Imiquimod"

    NDCBrand NameGeneric Name
    99207-270Zyclaraimiquimod
    99207-271Zyclaraimiquimod
    99207-276Zyclaraimiquimod
    99207-260Aldaraimiquimod
    0093-3133Imiquimodimiquimod
    0168-0432imiquimodimiquimod
    45802-368ImiquimodImiquimod
    51672-4145ImiquimodImiquimod
    51672-4174ImiquimodImiquimod
    52549-4145ImiquimodImiquimod
    63629-8818Imiquimodimiquimod
    64380-773imiquimodimiquimod
    68462-536ImiquimodImiquimod
    68682-272Imiquimodimiquimod
    72189-084IMIQUIMODIMIQUIMOD

    Trademark Results [Zyclara]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZYCLARA
    ZYCLARA
    85721208 4280040 Live/Registered
    Medicis Pharmaceutical Corporation
    2012-09-05
    ZYCLARA
    ZYCLARA
    77781257 3819643 Live/Registered
    MEDICIS PHARMACEUTICAL CORPORATION
    2009-07-15

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