duaklir pressair

Generic: aclidinium bromide and formoterol fumarate

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

Drug Facts

Product Profile

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

aclidinium bromide 400 ug/1, formoterol fumarate 12 ug/1

Manufacturer
Covis Pharma US, Inc

Identifiers & Regulatory

Product NDC 70515-001
Product ID 70515-001_2eba3089-28b4-4190-9fba-2511246cfd16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210595
Listing Expiration 2026-12-31
Marketing Start 2019-03-29

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] anticholinergic [epc] cholinergic antagonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70515001
Hyphenated Format 70515-001

Supplemental Identifiers

RxCUI
2205094 2205099 2205103 2205104
UNII
UQW7UF9N91 W34SHF8J2K

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 duaklir pressair (source: ndc)
Generic Name aclidinium bromide and formoterol fumarate (source: ndc)
Application Number NDA210595 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 400 ug/1
  • 12 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
  • 1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
source: ndc

Packages (2)

70515-001-01 1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER 70515-001-03 1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER

Ingredients (2)

aclidinium bromide (400 ug/1) formoterol fumarate (12 ug/1)

Linked Drug Pages (1)

DUAKLIR PRESSAIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "2eba3089-28b4-4190-9fba-2511246cfd16", "openfda": {"unii": ["UQW7UF9N91", "W34SHF8J2K"], "rxcui": ["2205094", "2205099", "2205103", "2205104"], "spl_set_id": ["2eba3089-28b4-4190-9fba-2511246cfd16"], "manufacturer_name": ["Covis Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (70515-001-01)  / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER", "package_ndc": "70515-001-01", "marketing_start_date": "20190329"}, {"sample": false, "description": "1 POUCH in 1 CARTON (70515-001-03)  / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER", "package_ndc": "70515-001-03", "marketing_start_date": "20190329"}], "brand_name": "DUAKLIR PRESSAIR", "product_id": "70515-001_2eba3089-28b4-4190-9fba-2511246cfd16", "dosage_form": "POWDER, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "70515-001", "generic_name": "aclidinium bromide and formoterol fumarate", "labeler_name": "Covis Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DUAKLIR PRESSAIR", "active_ingredients": [{"name": "ACLIDINIUM BROMIDE", "strength": "400 ug/1"}, {"name": "FORMOTEROL FUMARATE", "strength": "12 ug/1"}], "application_number": "NDA210595", "marketing_category": "NDA", "marketing_start_date": "20190329", "listing_expiration_date": "20261231"}