spiriva respimat

Generic: tiotropium bromide inhalation spray

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

Drug Facts

Product Profile

Brand Name spiriva respimat
Generic Name tiotropium bromide inhalation spray
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form SPRAY, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tiotropium bromide anhydrous 3.124 ug/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0100
Product ID 0597-0100_3a3c2a57-54e9-421c-9d5b-390076a40cc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021936
Listing Expiration 2026-12-31
Marketing Start 2014-09-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970100
Hyphenated Format 0597-0100

Supplemental Identifiers

RxCUI
1552002 1552004 1552008 1552009 1667880 1667882 1667885 1667886 2166203 2166204
UNII
XX112XZP0J

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 respimat (source: ndc)
Generic Name tiotropium bromide inhalation spray (source: ndc)
Application Number NDA021936 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 3.124 ug/1
source: ndc
Packaging
  • 1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE
  • 1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE
  • 1 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGE
source: ndc

Packages (3)

0597-0100-28 1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE 0597-0100-51 1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE 0597-0100-61 1 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGE

Ingredients (1)

tiotropium bromide anhydrous (3.124 ug/1)

Linked Drug Pages (1)

Spiriva Respimat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "3a3c2a57-54e9-421c-9d5b-390076a40cc4", "openfda": {"unii": ["XX112XZP0J"], "rxcui": ["1552002", "1552004", "1552008", "1552009", "1667880", "1667882", "1667885", "1667886", "2166203", "2166204"], "spl_set_id": ["7b656b14-fcaa-2741-f6f0-e0be48971c02"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0597-0100-28)  / 28 SPRAY, METERED in 1 CARTRIDGE", "package_ndc": "0597-0100-28", "marketing_start_date": "20140930"}, {"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0597-0100-51)  / 10 SPRAY, METERED in 1 CARTRIDGE", "package_ndc": "0597-0100-51", "marketing_start_date": "20190315"}, {"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0597-0100-61)  / 60 SPRAY, METERED in 1 CARTRIDGE", "package_ndc": "0597-0100-61", "marketing_start_date": "20140930"}], "brand_name": "Spiriva Respimat", "product_id": "0597-0100_3a3c2a57-54e9-421c-9d5b-390076a40cc4", "dosage_form": "SPRAY, METERED", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0597-0100", "generic_name": "tiotropium bromide inhalation spray", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spiriva Respimat", "active_ingredients": [{"name": "TIOTROPIUM BROMIDE ANHYDROUS", "strength": "3.124 ug/1"}], "application_number": "NDA021936", "marketing_category": "NDA", "marketing_start_date": "20140930", "listing_expiration_date": "20261231"}