spiriva handihaler

Generic: tiotropium bromide

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name spiriva handihaler
Generic Name tiotropium bromide
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL RESPIRATORY (INHALATION)
Active Ingredients

tiotropium bromide monohydrate 18 ug/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7645
Product ID 50090-7645_70e86c70-cb36-45d0-853c-9840b3dad9b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021395
Listing Expiration 2026-12-31
Marketing Start 2005-10-11

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907645
Hyphenated Format 50090-7645

Supplemental Identifiers

RxCUI
485032 580261
UNII
L64SXO195N

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name spiriva handihaler (source: ndc)
Generic Name tiotropium bromide (source: ndc)
Application Number NDA021395 (source: ndc)
Routes
ORAL RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 18 ug/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (50090-7645-0) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

50090-7645-0 3 BLISTER PACK in 1 CARTON (50090-7645-0) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

tiotropium bromide monohydrate (18 ug/1)

Linked Drug Pages (1)

Spiriva HandiHaler ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RESPIRATORY (INHALATION)"], "spl_id": "70e86c70-cb36-45d0-853c-9840b3dad9b9", "openfda": {"unii": ["L64SXO195N"], "rxcui": ["485032", "580261"], "spl_set_id": ["c6343458-617b-41ed-8e96-763e91dc8e90"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50090-7645-0)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "50090-7645-0", "marketing_start_date": "20250829"}], "brand_name": "Spiriva HandiHaler", "product_id": "50090-7645_70e86c70-cb36-45d0-853c-9840b3dad9b9", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "50090-7645", "generic_name": "TIOTROPIUM BROMIDE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spiriva", "brand_name_suffix": "HandiHaler", "active_ingredients": [{"name": "TIOTROPIUM BROMIDE MONOHYDRATE", "strength": "18 ug/1"}], "application_number": "NDA021395", "marketing_category": "NDA", "marketing_start_date": "20051011", "listing_expiration_date": "20261231"}