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United States · US · US:0597-0100_3a3c2a57-54e9-421c-9d5b-390076a40cc4
Spiriva Respimat
Orange BookUNIISPLATC R03BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1105970100281 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE
- ndc1105970100511 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE
- ndc1105970100611 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
XX112XZP0J
TIOTROPIUM BROMIDE ANHYDROUS
RxCUI 393575
Orange Book
N021936
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XX112XZP0J",
"rxcui": "393575",
"inchikey": "DQHNAVOVODVIMG-FOGIBKMMSA-M",
"display_name": "TIOTROPIUM BROMIDE ANHYDROUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"7b656b14-fcaa-2741-f6f0-e0be48971c02": {
"match": "brand_token",
"title": "SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "14",
"published_date": "2025-12-04"
}
},
"productid": "0597-0100_3a3c2a57-54e9-421c-9d5b-390076a40cc4",
"productndc": "0597-0100",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "021936",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.0025MG BASE/INH",
"product_no": "001",
"approval_date": "Sep 24, 2014"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.00125MG BASE/INH",
"product_no": "002",
"approval_date": "Sep 15, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIOTROPIUM BROMIDE ANHYDROUS",
"proprietary_name": "Spiriva Respimat",
"active_ingred_unit": "ug/1",
"application_number": "NDA021936",
"marketing_category": "NDA",
"nonproprietary_name": "tiotropium bromide inhalation spray",
"start_marketing_date": "20140930",
"active_numerator_strength": "3.124"
}Related drugs
Other records sharing ATC code R03BB04.
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