spiriva handihaler

Generic: tiotropium bromide

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name spiriva handihaler
Generic Name tiotropium bromide
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL RESPIRATORY (INHALATION)
Active Ingredients

tiotropium bromide monohydrate 18 ug/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0075
Product ID 0597-0075_94768574-0d3e-46f0-9f75-ab3c9f52857d
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 05970075
Hyphenated Format 0597-0075

Supplemental Identifiers

RxCUI
485032 580261
UNII
L64SXO195N

Packaging Origin

Original Packager
true

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 (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK
  • 9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (0597-0075-75) / 5 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

0597-0075-41 3 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK 0597-0075-47 9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK 0597-0075-75 1 BLISTER PACK in 1 CARTON (0597-0075-75) / 5 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": "94768574-0d3e-46f0-9f75-ab3c9f52857d", "openfda": {"unii": ["L64SXO195N"], "rxcui": ["485032", "580261"], "spl_set_id": ["820839ef-e53d-47e8-a3b9-d911ff92e6a9"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0597-0075-41)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "0597-0075-41", "marketing_start_date": "20051011"}, {"sample": false, "description": "9 BLISTER PACK in 1 CARTON (0597-0075-47)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "0597-0075-47", "marketing_start_date": "20051011"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0597-0075-75)  / 5 CAPSULE in 1 BLISTER PACK", "package_ndc": "0597-0075-75", "marketing_start_date": "20051011"}], "brand_name": "Spiriva HandiHaler", "product_id": "0597-0075_94768574-0d3e-46f0-9f75-ab3c9f52857d", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0597-0075", "generic_name": "TIOTROPIUM BROMIDE", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "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"}