NDC 72124-001 Duaklir Pressair

Aclidinium Bromide And Formoterol Fumarte

NDC Product Code 72124-001

NDC 72124-001-01

Package Description: 1 POUCH in 1 CARTON > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER

NDC 72124-001-03

Package Description: 1 POUCH in 1 CARTON > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER

NDC Product Information

Duaklir Pressair with NDC 72124-001 is a a human prescription drug product labeled by Circassia Pharmaceuticals Inc.. The generic name of Duaklir Pressair is aclidinium bromide and formoterol fumarte. The product's dosage form is powder, metered and is administered via respiratory (inhalation) form.

Labeler Name: Circassia Pharmaceuticals Inc.

Dosage Form: Powder, Metered - An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Duaklir Pressair Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACLIDINIUM BROMIDE 400 ug/1
  • FORMOTEROL FUMARATE 12 ug/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Circassia Pharmaceuticals Inc.
Labeler Code: 72124
FDA Application Number: NDA210595 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-11-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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