NDC 72124-002

Tudorza Pressair

Aclidinium Bromide

Tudorza Pressair is a Respiratory (inhalation) Powder, Metered in the Human Prescription Drug category. It is labeled and distributed by Circassia Pharmaceuticals Inc.. The primary component is Aclidinium Bromide.

Product ID72124-002_46c6166f-9807-4fd3-87a0-ae7112b9d842
NDC72124-002
Product TypeHuman Prescription Drug
Proprietary NameTudorza Pressair
Generic NameAclidinium Bromide
Dosage FormPowder, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-07-01
Marketing CategoryNDA / NDA
Application NumberNDA202450
Labeler NameCircassia Pharmaceuticals Inc.
Substance NameACLIDINIUM BROMIDE
Active Ingredient Strength400 ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72124-002-01

1 POUCH in 1 CARTON (72124-002-01) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER
Marketing Start Date2019-07-01
Marketing End Date2023-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72124-002-60 [72124000260]

Tudorza Pressair POWDER, METERED
Marketing CategoryNDA
Application NumberNDA202450
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01
Marketing End Date2019-07-02

NDC 72124-002-02 [72124000202]

Tudorza Pressair POWDER, METERED
Marketing CategoryNDA
Application NumberNDA202450
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-01

NDC 72124-002-01 [72124000201]

Tudorza Pressair POWDER, METERED
Marketing CategoryNDA
Application NumberNDA202450
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-01

NDC 72124-002-03 [72124000203]

Tudorza Pressair POWDER, METERED
Marketing CategoryNDA
Application NumberNDA202450
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
ACLIDINIUM BROMIDE400 ug/1

OpenFDA Data

SPL SET ID:4cefdf4c-9e01-4b98-804b-c520f1b9716e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1303107
  • 1607112
  • 1607111
  • 1303102
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Tudorza Pressair" or generic name "Aclidinium Bromide"

    NDCBrand NameGeneric Name
    0310-0800Tudorza Pressairaclidinium bromide
    72124-002Tudorza Pressairaclidinium bromide

    Trademark Results [Tudorza Pressair]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TUDORZA PRESSAIR
    TUDORZA PRESSAIR
    85896045 4509395 Live/Registered
    Almirall, S.A.
    2013-04-05
    TUDORZA PRESSAIR
    TUDORZA PRESSAIR
    85853924 4490481 Live/Registered
    Almirall, S.A.
    2013-02-19

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