NDC 72124-001

DUAKLIR PRESSAIR

Aclidinium Bromide And Formoterol Fumarte

DUAKLIR 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; Formoterol Fumarate.

Product ID72124-001_10a317df-3ce1-4d4d-ba04-8fab97d186e1
NDC72124-001
Product TypeHuman Prescription Drug
Proprietary NameDUAKLIR PRESSAIR
Generic NameAclidinium Bromide And Formoterol Fumarte
Dosage FormPowder, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-10-11
Marketing CategoryNDA / NDA
Application NumberNDA210595
Labeler NameCircassia Pharmaceuticals Inc.
Substance NameACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Active Ingredient Strength400 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 72124-001-01

1 POUCH in 1 CARTON (72124-001-01) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER
Marketing Start Date2019-10-11
Marketing End Date2022-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72124-001-03 [72124000103]

DUAKLIR PRESSAIR POWDER, METERED
Marketing CategoryNDA
Application NumberNDA210595
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-11

NDC 72124-001-01 [72124000101]

DUAKLIR PRESSAIR POWDER, METERED
Marketing CategoryNDA
Application NumberNDA210595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
ACLIDINIUM BROMIDE400 ug/1

Pharmacological Class

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

NDC Crossover Matching brand name "DUAKLIR PRESSAIR" or generic name "Aclidinium Bromide And Formoterol Fumarte"

NDCBrand NameGeneric Name
0310-0900DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarate
72124-001DUAKLIR PRESSAIRaclidinium bromide and formoterol fumarte
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