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 ID: 72124-002_46c6166f-9807-4fd3-87a0-ae7112b9d842
• NDC: 72124-002
• Product Type: Human Prescription Drug
• Proprietary Name: Tudorza Pressair
• Generic Name: Aclidinium Bromide
• Dosage Form: Powder, Metered
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2019-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA202450
• Labeler Name: Circassia Pharmaceuticals Inc.
• Substance Name: ACLIDINIUM BROMIDE
• Active Ingredient Strength: 400 ug/1
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2019-07-01
• Marketing End Date: 2023-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72124-002-60 [72124000260]

Tudorza Pressair POWDER, METERED

• Marketing Category: NDA
• Application Number: NDA202450
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01
• Marketing End Date: 2019-07-02

NDC 72124-002-02 [72124000202]

Tudorza Pressair POWDER, METERED

• Marketing Category: NDA
• Application Number: NDA202450
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-01

NDC 72124-002-01 [72124000201]

Tudorza Pressair POWDER, METERED

• Marketing Category: NDA
• Application Number: NDA202450
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-01

NDC 72124-002-03 [72124000203]

Tudorza Pressair POWDER, METERED

• Marketing Category: NDA
• Application Number: NDA202450
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

Drug Details

Active Ingredients

Ingredient	Strength
ACLIDINIUM BROMIDE	400 ug/1

OpenFDA Data

• SPL SET ID: 4cefdf4c-9e01-4b98-804b-c520f1b9716e
• Manufacturer:
  • Circassia Pharmaceuticals Inc.
• UNII:
  • UQW7UF9N91
• 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"

NDC	Brand Name	Generic Name
0310-0800	Tudorza Pressair	aclidinium bromide
72124-002	Tudorza Pressair	aclidinium bromide