NDC 0597-0075

Spiriva HandiHaler

Tiotropium Bromide

Spiriva HandiHaler is a Oral; Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Tiotropium Bromide Monohydrate.

Product ID0597-0075_61e158db-bf32-4cb5-8e5e-72acd953e493
NDC0597-0075
Product TypeHuman Prescription Drug
Proprietary NameSpiriva HandiHaler
Generic NameTiotropium Bromide
Dosage FormCapsule
Route of AdministrationORAL; RESPIRATORY (INHALATION)
Marketing Start Date2005-10-11
Marketing CategoryNDA / NDA
Application NumberNDA021395
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameTIOTROPIUM BROMIDE MONOHYDRATE
Active Ingredient Strength18 ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0597-0075-41

3 BLISTER PACK in 1 CARTON (0597-0075-41) > 10 CAPSULE in 1 BLISTER PACK
Marketing Start Date2005-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0075-06 [00597007506]

Spiriva HandiHaler CAPSULE
Marketing CategoryNDA
Application NumberNDA021395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-29
Marketing End Date2011-07-28

NDC 0597-0075-47 [00597007547]

Spiriva HandiHaler CAPSULE
Marketing CategoryNDA
Application NumberNDA021395
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11

NDC 0597-0075-37 [00597007537]

Spiriva HandiHaler CAPSULE
Marketing CategoryNDA
Application NumberNDA021395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-29
Marketing End Date2011-07-28

NDC 0597-0075-12 [00597007512]

Spiriva HandiHaler CAPSULE
Marketing CategoryNDA
Application NumberNDA021395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-29
Marketing End Date2011-07-28

NDC 0597-0075-27 [00597007527]

Spiriva HandiHaler CAPSULE
Marketing CategoryNDA
Application NumberNDA021395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-11
Marketing End Date2017-10-25

NDC 0597-0075-75 [00597007575]

Spiriva HandiHaler CAPSULE
Marketing CategoryNDA
Application NumberNDA021395
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11

NDC 0597-0075-41 [00597007541]

Spiriva HandiHaler CAPSULE
Marketing CategoryNDA
Application NumberNDA021395
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-11

Drug Details

Active Ingredients

IngredientStrength
TIOTROPIUM BROMIDE MONOHYDRATE18 ug/1

OpenFDA Data

SPL SET ID:820839ef-e53d-47e8-a3b9-d911ff92e6a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485032
  • 580261

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Spiriva HandiHaler" or generic name "Tiotropium Bromide"

    NDCBrand NameGeneric Name
    0597-0075SpirivaTIOTROPIUM BROMIDE
    50090-4248SpirivaTIOTROPIUM BROMIDE
    50090-4414SpirivaTIOTROPIUM BROMIDE

    Trademark Results [Spiriva]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SPIRIVA
    SPIRIVA
    79002090 2998420 Dead/Cancelled
    Boehringer Ingelheim Pharma GmbH & Co. KG
    2004-03-18
    SPIRIVA
    SPIRIVA
    78335207 3005009 Live/Registered
    Boehringer Ingelheim Pharma GmbH & Co. KG
    2003-12-02
    SPIRIVA
    SPIRIVA
    75575954 2285506 Live/Registered
    Boehringer Ingelheim Pharma GmbH & Co. K
    1998-10-22
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