🇺🇸
United States · US · US:0597-0155_79996212-633b-464e-9967-834039fb13a4
Stiolto Respimat
Orange BookUNIISPLATC R03AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1105970155281 CARTRIDGE in 1 CARTON (0597-0155-28) / 28 SPRAY, METERED in 1 CARTRIDGE
- ndc1105970155611 CARTRIDGE in 1 CARTON (0597-0155-61) / 60 SPRAY, METERED in 1 CARTRIDGE
- ndc1105970155701 CARTRIDGE in 1 CARTON (0597-0155-70) / 10 SPRAY, METERED in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
65R445W3V9
OLODATEROL HYDROCHLORIDE
RxCUI 1546396
Orange Book
N206756
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "65R445W3V9",
"rxcui": "1546396",
"inchikey": "KCEHVJZZIGJAAW-FERBBOLQSA-N",
"display_name": "OLODATEROL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"01e15aee-40e0-23f3-537f-c96dd63e2cb1": {
"match": "brand_token",
"title": "STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "16",
"published_date": "2025-07-16"
}
},
"productid": "0597-0155_79996212-633b-464e-9967-834039fb13a4",
"productndc": "0597-0155",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "206756",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH",
"product_no": "001",
"approval_date": "May 21, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE MONOHYDRATE",
"proprietary_name": "Stiolto Respimat",
"active_ingred_unit": "ug/1; ug/1",
"application_number": "NDA206756",
"marketing_category": "NDA",
"nonproprietary_name": "tiotropium bromide and olodaterol",
"start_marketing_date": "20150521",
"active_numerator_strength": "2.736; 3.124"
}Related drugs
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