tudorza pressair

Generic: aclidinium bromide

Labeler: covis pharma us, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tudorza pressair
Generic Name aclidinium bromide
Labeler covis pharma us, inc
Dosage Form POWDER, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

aclidinium bromide 400 ug/1

Manufacturer
Covis Pharma US, Inc

Identifiers & Regulatory

Product NDC 70515-002
Product ID 70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202450
Listing Expiration 2026-12-31
Marketing Start 2015-07-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70515002
Hyphenated Format 70515-002

Supplemental Identifiers

RxCUI
1303102 1303107 1607111 1607112
UNII
UQW7UF9N91

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tudorza pressair (source: ndc)
Generic Name aclidinium bromide (source: ndc)
Application Number NDA202450 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 400 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
  • 1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
  • 1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
source: ndc

Packages (3)

70515-002-01 1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER 70515-002-02 1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER 70515-002-03 1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER

Ingredients (1)

aclidinium bromide (400 ug/1)

Linked Drug Pages (1)

Tudorza Pressair ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "86a2e74d-bbf7-4de6-af00-3d23ee80630a", "openfda": {"unii": ["UQW7UF9N91"], "rxcui": ["1303102", "1303107", "1607111", "1607112"], "spl_set_id": ["6f92cceb-a63f-4470-99b6-56179d98f10f"], "manufacturer_name": ["Covis Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (70515-002-01)  / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER", "package_ndc": "70515-002-01", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 POUCH in 1 CARTON (70515-002-02)  / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER", "package_ndc": "70515-002-02", "marketing_start_date": "20150701"}, {"sample": true, "description": "1 POUCH in 1 CARTON (70515-002-03)  / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER", "package_ndc": "70515-002-03", "marketing_start_date": "20150701"}], "brand_name": "Tudorza Pressair", "product_id": "70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630a", "dosage_form": "POWDER, METERED", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "70515-002", "generic_name": "aclidinium bromide", "labeler_name": "Covis Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tudorza Pressair", "active_ingredients": [{"name": "ACLIDINIUM BROMIDE", "strength": "400 ug/1"}], "application_number": "NDA202450", "marketing_category": "NDA", "marketing_start_date": "20150701", "listing_expiration_date": "20261231"}