NDC 0085-4610

Dulera

Mometasone Furoate And Formoterol Fumarate Dihydrate

Dulera is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Mometasone Furoate; Formoterol Fumarate.

Product ID0085-4610_04037d69-9f54-40cb-82be-0435ac135c01
NDC0085-4610
Product TypeHuman Prescription Drug
Proprietary NameDulera
Generic NameMometasone Furoate And Formoterol Fumarate Dihydrate
Dosage FormAerosol
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2010-06-22
Marketing CategoryNDA / NDA
Application NumberNDA022518
Labeler NameMerck Sharp & Dohme Corp.
Substance NameMOMETASONE FUROATE; FORMOTEROL FUMARATE
Active Ingredient Strength200 ug/1; ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0085-4610-01

1 CANISTER in 1 CARTON (0085-4610-01) > 120 AEROSOL in 1 CANISTER
Marketing Start Date2010-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0085-4610-01 [00085461001]

Dulera AEROSOL
Marketing CategoryNDA
Application NumberNDA022518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2010-06-22

NDC 0085-4610-06 [00085461006]

Dulera AEROSOL
Marketing CategoryNDA
Application NumberNDA022518
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-22

NDC 0085-4610-05 [00085461005]

Dulera AEROSOL
Marketing CategoryNDA
Application NumberNDA022518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2010-06-22

NDC 0085-4610-02 [00085461002]

Dulera AEROSOL
Marketing CategoryNDA
Application NumberNDA022518
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-22

Drug Details

Active Ingredients

IngredientStrength
MOMETASONE FUROATE200 ug/1

OpenFDA Data

SPL SET ID:116464ce-cfd8-4b9f-8b5a-3a114b6ff2b1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1660937
  • 1660934
  • 1246308
  • 1246313
  • 1246310
  • 1246311
  • 1660938
  • 1660933
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Dulera" or generic name "Mometasone Furoate And Formoterol Fumarate Dihydrate"

    NDCBrand NameGeneric Name
    0085-2223Duleramometasone furoate and formoterol fumarate dihydrate
    0085-4610Duleramometasone furoate and formoterol fumarate dihydrate
    0085-7206Duleramometasone furoate and formoterol fumarate dihydrate
    50090-1916Duleramometasone furoate and formoterol fumarate dihydrate
    78206-125Duleramometasone furoate and formoterol fumarate dihydrate
    78206-126Duleramometasone furoate and formoterol fumarate dihydrate
    78206-127Duleramometasone furoate and formoterol fumarate dihydrate

    Trademark Results [Dulera]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DULERA
    DULERA
    77651927 not registered Dead/Abandoned
    Schering Corporation
    2009-01-19
    DULERA
    DULERA
    77651926 not registered Dead/Abandoned
    Schering Corporation
    2009-01-19
    DULERA
    DULERA
    77194640 not registered Dead/Abandoned
    MSP SINGAPORE COMPANY, LLC
    2007-05-31
    DULERA
    DULERA
    77194631 not registered Dead/Abandoned
    MSP SINGAPORE COMPANY, LLC
    2007-05-31
    DULERA
    DULERA
    77095855 3419361 Live/Registered
    MERCK SHARP & DOHME CORP.
    2007-01-31

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