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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
- ndc1170515001011 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
- ndc1170515001031 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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- 🇪🇸ANORO ELLIPTA 55 MCG/22 MCG POLVO PARA INHALACION (UNIDOSIS)Glaxosmithkline (Ireland) Limited
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