NDC 63402-911

Brovana

Arformoterol Tartrate

Brovana is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Arformoterol Tartrate.

Product ID63402-911_2958732d-0046-49fc-8f28-b36959252832
NDC63402-911
Product TypeHuman Prescription Drug
Proprietary NameBrovana
Generic NameArformoterol Tartrate
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2007-04-01
Marketing CategoryNDA / NDA
Application NumberNDA021912
Labeler NameSunovion Pharmaceuticals Inc.
Substance NameARFORMOTEROL TARTRATE
Active Ingredient Strength15 ug/2mL
Pharm ClassesAdrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63402-911-08

2 POUCH in 1 CARTON (63402-911-08) > 4 VIAL, SINGLE-DOSE in 1 POUCH (63402-911-03) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2007-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63402-911-30 [63402091130]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-04-01

NDC 63402-911-64 [63402091164]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-04-01

NDC 63402-911-04 [63402091104]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-30

NDC 63402-911-31 [63402091131]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-01

NDC 63402-911-08 [63402091108]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-01

NDC 63402-911-01 [63402091101]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-30

NDC 63402-911-02 [63402091102]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-14

NDC 63402-911-03 [63402091103]

Brovana SOLUTION
Marketing CategoryNDA
Application NumberNDA021912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-14

Drug Details

Active Ingredients

IngredientStrength
ARFORMOTEROL TARTRATE15 ug/2mL

OpenFDA Data

SPL SET ID:7134ae7c-6c64-470d-ab4e-81e35413b839
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 668956
  • 695935
    • UPC Code
  • 0363402911047

    • Pharmacological Class

    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    Medicade Reported Pricing

    63402091164 BROVANA 15 MCG/2 ML SOLUTION

    Pricing Unit: ML | Drug Type:

    63402091130 BROVANA 15 MCG/2 ML SOLUTION

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Brovana" or generic name "Arformoterol Tartrate"

    NDCBrand NameGeneric Name
    63402-911Brovanaarformoterol tartrate
    0093-5955Arformoterol tartrateArformoterol tartrate
    62332-633Arformoterol tartrateArformoterol tartrate
    62756-277Arformoterol TartrateArformoterol Tartrate
    68462-833ARFORMOTEROL TARTRATEarformoterol tartrate
    69097-168arformoterol tartratearformoterol tartrate
    70748-175Arformoterol tartrateArformoterol tartrate
    70748-257Arformoterol TartrateArformoterol Tartrate
    70756-612arformoterol tartratearformoterol tartrate

    Trademark Results [Brovana]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BROVANA
    BROVANA
    78839188 3321338 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2006-03-16
    BROVANA
    BROVANA
    77172553 3838252 Dead/Cancelled
    SUNOVION PHARMACEUTICALS INC.
    2007-05-03
    BROVANA
    BROVANA
    77172498 3845569 Dead/Cancelled
    SUNOVION PHARMACEUTICALS INC.
    2007-05-03
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