NDC 0597-0192

Striverdi Respimat

Olodaterol Respimat Inhalation Spray

Striverdi 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 Olodaterol Hydrochloride.

Product ID0597-0192_21100130-bc7c-267d-8a44-55972f98f5fe
NDC0597-0192
Product TypeHuman Prescription Drug
Proprietary NameStriverdi Respimat
Generic NameOlodaterol Respimat Inhalation Spray
Dosage FormSpray, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2014-08-01
Marketing CategoryNDA / NDA
Application NumberNDA203108
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameOLODATEROL HYDROCHLORIDE
Active Ingredient Strength3 ug/1
Pharm Classesbeta2-Adrenergic Agonist [EPC],Adrenergic beta2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0597-0192-61

1 CARTRIDGE in 1 CARTON (0597-0192-61) > 60 SPRAY, METERED in 1 CARTRIDGE
Marketing Start Date2014-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0192-61 [00597019261]

Striverdi Respimat SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA203108
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-08-01

NDC 0597-0192-31 [00597019231]

Striverdi Respimat SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA203108
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-08-01
Marketing End Date2016-06-23

NDC 0597-0192-28 [00597019228]

Striverdi Respimat SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA203108
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-01
Marketing End Date2017-03-31

Drug Details

Active Ingredients

IngredientStrength
OLODATEROL HYDROCHLORIDE2.5 ug/1

OpenFDA Data

SPL SET ID:5d9a5433-857e-44ea-b3d6-2a400ca0cef5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1546083
  • 1546077
  • 1546082
  • 1546079
  • Pharmacological Class

    • beta2-Adrenergic Agonist [EPC]
    • Adrenergic beta2-Agonists [MoA]

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