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United States · US · US:68180-964_87de16e4-1447-4bf6-90f6-705829efe684
Tiotropium Bromide
Orange BookUNIISPLATC R03BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168180964123 BLISTER PACK in 1 CARTON (68180-964-12) / 10 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
L64SXO195N
TIOTROPIUM BROMIDE MONOHYDRATE
RxCUI 1298831
Orange Book
A211287
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": {
"496b38ee-45b6-4bb2-a35e-9023c3b73719": {
"match": "brand_token",
"title": "TIOTROPIUM BROMIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]",
"spl_version": "9",
"published_date": "2025-11-17"
}
},
"productid": "68180-964_87de16e4-1447-4bf6-90f6-705829efe684",
"productndc": "68180-964",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211287",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.018MG BASE/INH",
"product_no": "001",
"approval_date": "Jun 20, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIOTROPIUM BROMIDE MONOHYDRATE",
"proprietary_name": "Tiotropium Bromide",
"active_ingred_unit": "ug/1",
"application_number": "ANDA211287",
"marketing_category": "ANDA",
"nonproprietary_name": "Tiotropium Bromide",
"start_marketing_date": "20230816",
"active_numerator_strength": "18"
}Related drugs
Other records sharing ATC code R03BB04.
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