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United States · US · US:70515-001_2eba3089-28b4-4190-9fba-2511246cfd16

DUAKLIR PRESSAIR

Orange BookUNIISPLATC R03BB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCovis Pharma US, Inc
CountryUS (United States)
ATC codeR03BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7051500101
    1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
  • ndc11
    7051500103
    1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)
UQW7UF9N91
ACLIDINIUM BROMIDE
RxCUI 1303097
Orange Book
N210595
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "UQW7UF9N91",
    "rxcui": "1303097",
    "inchikey": "XLAKJQPTOJHYDR-QTQXQZBYSA-M",
    "display_name": "ACLIDINIUM BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "2eba3089-28b4-4190-9fba-2511246cfd16": {
      "match": "brand_token",
      "title": "DUAKLIR PRESSAIR (ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE) POWDER, METERED [COVIS PHARMA US, INC]",
      "spl_version": "1",
      "published_date": "2023-12-08"
    }
  },
  "productid": "70515-001_2eba3089-28b4-4190-9fba-2511246cfd16",
  "productndc": "70515-001",
  "dosage_form": "POWDER, METERED",
  "orange_book": {
    "appl_no": "210595",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG/INH;0.012MG/INH",
        "product_no": "001",
        "approval_date": "Mar 29, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE",
  "proprietary_name": "DUAKLIR PRESSAIR",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA210595",
  "marketing_category": "NDA",
  "nonproprietary_name": "aclidinium bromide and formoterol fumarate",
  "start_marketing_date": "20190329",
  "active_numerator_strength": "400; 12"
}

Related drugs

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