NDC 0310-4600

BEVESPI AEROSPHERE

Glycopyrrolate And Formoterol Fumarate

BEVESPI AEROSPHERE is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Glycopyrrolate; Formoterol Fumarate.

Product ID0310-4600_2c971eda-1bea-4e0e-a272-bafda4e86303
NDC0310-4600
Product TypeHuman Prescription Drug
Proprietary NameBEVESPI AEROSPHERE
Generic NameGlycopyrrolate And Formoterol Fumarate
Dosage FormAerosol, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2016-10-03
Marketing CategoryNDA / NDA
Application NumberNDA208294
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameGLYCOPYRROLATE; FORMOTEROL FUMARATE
Active Ingredient Strength9 ug/1; ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0310-4600-12

120 AEROSOL, METERED in 1 INHALER (0310-4600-12)
Marketing Start Date2016-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-4600-39 [00310460039]

BEVESPI AEROSPHERE AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA208294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-08-01

NDC 0310-4600-28 [00310460028]

BEVESPI AEROSPHERE AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA208294
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-01

NDC 0310-4600-12 [00310460012]

BEVESPI AEROSPHERE AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA208294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-10-03

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE9 ug/1

OpenFDA Data

SPL SET ID:ae02436e-9528-490e-a844-0c0f6f2843f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790639
  • 1790644

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    Trademark Results [BEVESPI AEROSPHERE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BEVESPI AEROSPHERE
    BEVESPI AEROSPHERE
    86637446 4991372 Live/Registered
    AstraZeneca AB
    2015-05-21
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