NDC 0597-0155

Stiolto Respimat

Tiotropium Bromide And Olodaterol

Stiolto Respimat is a Respiratory (inhalation) Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals Inc.. The primary component is Tiotropium Bromide Monohydrate; Olodaterol Hydrochloride.

Product ID0597-0155_0ae2698c-8f15-8481-9173-45caaaa3ef5c
NDC0597-0155
Product TypeHuman Prescription Drug
Proprietary NameStiolto Respimat
Generic NameTiotropium Bromide And Olodaterol
Dosage FormSpray, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2015-05-21
Marketing CategoryNDA / NDA
Application NumberNDA206756
Labeler NameBoehringer Ingelheim Pharmaceuticals Inc.
Substance NameTIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE
Active Ingredient Strength3 ug/1; ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],beta2-Adrenergic Agonist [EPC],Adrenergic beta2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0597-0155-28

1 CARTRIDGE in 1 CARTON (0597-0155-28) > 28 SPRAY, METERED in 1 CARTRIDGE
Marketing Start Date2015-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0155-31 [00597015531]

Stiolto Respimat SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA206756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-07-02

NDC 0597-0155-61 [00597015561]

Stiolto Respimat SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA206756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-05-21

NDC 0597-0155-28 [00597015528]

Stiolto Respimat SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA206756
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-21

NDC 0597-0155-70 [00597015570]

Stiolto Respimat SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA206756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-03-22

Drug Details

Active Ingredients

IngredientStrength
TIOTROPIUM BROMIDE MONOHYDRATE3.124 ug/1

OpenFDA Data

SPL SET ID:01e15aee-40e0-23f3-537f-c96dd63e2cb1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1651266
  • 1651271
  • 1651275
  • 1651274

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • beta2-Adrenergic Agonist [EPC]
    • Adrenergic beta2-Agonists [MoA]

    Trademark Results [Stiolto Respimat]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STIOLTO RESPIMAT
    STIOLTO RESPIMAT
    88237756 not registered Live/Pending
    Boehringer Ingelheim International GmbH
    2018-12-20
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