🇺🇸
United States · US · US:50090-4248_fa0b0258-3ff1-4481-a289-2599b2e3fd76
Spiriva
Orange BookUNIISPLATC R03BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR03BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090424803 BLISTER PACK in 1 CARTON (50090-4248-0) / 10 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
L64SXO195N
TIOTROPIUM BROMIDE MONOHYDRATE
RxCUI 1298831
Orange Book
N021395
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L64SXO195N",
"rxcui": "1298831",
"inchikey": "MQLXPRBEAHBZTK-SEINRUQRSA-M",
"display_name": "TIOTROPIUM BROMIDE MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL; 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": "50090-4248_fa0b0258-3ff1-4481-a289-2599b2e3fd76",
"productndc": "50090-4248",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021395",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.018MG BASE/INH",
"product_no": "001",
"approval_date": "Jan 30, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIOTROPIUM BROMIDE MONOHYDRATE",
"proprietary_name": "Spiriva",
"active_ingred_unit": "ug/1",
"application_number": "NDA021395",
"marketing_category": "NDA",
"nonproprietary_name": "TIOTROPIUM BROMIDE",
"start_marketing_date": "20051011",
"active_numerator_strength": "18"
}Related drugs
Other records sharing ATC code R03BB04.
Access this data programmatically
Query Spiriva 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.