NDC 0186-0916

PULMICORT FLEXHALER

Budesonide

PULMICORT FLEXHALER is a Respiratory (inhalation) Aerosol, Powder in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Budesonide.

Product ID0186-0916_0cf571de-53d5-4c3d-89a6-abf4d6ce52db
NDC0186-0916
Product TypeHuman Prescription Drug
Proprietary NamePULMICORT FLEXHALER
Generic NameBudesonide
Dosage FormAerosol, Powder
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2007-03-19
Marketing CategoryNDA / NDA
Application NumberNDA021949
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameBUDESONIDE
Active Ingredient Strength180 ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0186-0916-12

1 INHALER in 1 CARTON (0186-0916-12) > 120 AEROSOL, POWDER in 1 INHALER
Marketing Start Date2007-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0186-0916-65 [00186091665]

PULMICORT FLEXHALER AEROSOL, POWDER
Marketing CategoryNDA
Application NumberNDA021949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-19
Marketing End Date2019-09-19

NDC 0186-0916-12 [00186091612]

PULMICORT FLEXHALER AEROSOL, POWDER
Marketing CategoryNDA
Application NumberNDA021949
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-19

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE180 ug/1

OpenFDA Data

SPL SET ID:54234b7d-3bcc-4809-1881-1d21484856a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 966527
  • 966524
  • 966522
  • 966529
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "PULMICORT FLEXHALER" or generic name "Budesonide"

    NDCBrand NameGeneric Name
    21695-291PULMICORT FLEXHALERPULMICORT FLEXHALER
    50090-2239PULMICORT FLEXHALERPULMICORT FLEXHALER
    0093-6815BudesonideBudesonide
    0093-6816BudesonideBudesonide
    0093-6817BudesonideBudesonide
    0093-7445BudesonideBudesonide
    0115-1687Budesonide InhalationBudesonide
    0115-1689Budesonide InhalationBudesonide
    0186-0916PULMICORTBudesonide
    0186-0917PULMICORTBudesonide
    0186-1988PULMICORT RESPULESBudesonide
    0186-1989PULMICORT RESPULESBudesonide
    0186-1990PULMICORT RESPULESBudesonide

    Trademark Results [PULMICORT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PULMICORT
    PULMICORT
    78942523 3506648 Live/Registered
    AstraZeneca AB
    2006-08-01
    PULMICORT
    PULMICORT
    75001471 not registered Dead/Abandoned
    ASTRA AKTIEBOLAG
    1995-10-04
    PULMICORT
    PULMICORT
    73055022 1036567 Dead/Expired
    AKTIEBOLAGET ASTRA
    1975-08-28

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