🇺🇸
United States · US · US:70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630a
Tudorza Pressair
Orange BookUNIISPLATC R03BB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCovis Pharma US, Inc
CountryUS (United States)
ATC codeR03BB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1170515002011 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
- ndc1170515002021 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
- ndc1170515002031 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
Annotations
UNII (FDA Substance ID)
UQW7UF9N91
ACLIDINIUM BROMIDE
RxCUI 1303097
Orange Book
N202450
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": {
"6f92cceb-a63f-4470-99b6-56179d98f10f": {
"match": "brand_token",
"title": "TUDORZA PRESSAIR (ACLIDINIUM BROMIDE) POWDER, METERED [COVIS PHARMA US, INC]",
"spl_version": "2",
"published_date": "2023-12-08"
}
},
"productid": "70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630a",
"productndc": "70515-002",
"dosage_form": "POWDER, METERED",
"orange_book": {
"appl_no": "202450",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.4MG/INH",
"product_no": "001",
"approval_date": "Jul 23, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACLIDINIUM BROMIDE",
"proprietary_name": "Tudorza Pressair",
"active_ingred_unit": "ug/1",
"application_number": "NDA202450",
"marketing_category": "NDA",
"nonproprietary_name": "aclidinium bromide",
"start_marketing_date": "20150701",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code R03BB05.
- GBAclidinium bromide 375micrograms/dose dry powder inhalerJ M McGill Ltd
- GBAclidinium bromide 375micrograms/dose dry powder inhalerColorama Pharmaceuticals Ltd
- GBAclidinium bromide 375micrograms/dose dry powder inhalerNiche Pharma Ltd
- FIBretaris GenuairCOVIS PHARMA EUROPE B.V.
- DKBretaris GenuairCovis Pharma Europe B.V.
- ISBretaris GenuairCovis Pharma Europe B.V.
- PLBretaris GenuairCovis Pharma Europe B.V.
- CZBRETARIS GENUAIRCovis Pharma Europe B.V., Amsterdam
Access this data programmatically
Query Tudorza Pressair and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.