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    NDC 00597-0155-28 Stiolto Respimat 2.736; 3.124 ug/1; ug/1 Details

    Stiolto Respimat 2.736; 3.124 ug/1; ug/1

    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 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE MONOHYDRATE.

    Product Information

    NDC 00597-0155
    Product ID 0597-0155_dd969dec-1e23-4cac-a42b-2f7f06a07f13
    Associated GPIs 44209902923420
    GCN Sequence Number 074131
    GCN Sequence Number Description tiotropium Br/olodaterol HCl MIST INHAL 2.5-2.5MCG INHALATION
    HIC3 B62
    HIC3 Description BETA-ADRENERGIC AND ANTICHOLINERGIC COMBO, INHALED
    GCN 38687
    HICL Sequence Number 042048
    HICL Sequence Number Description TIOTROPIUM BROMIDE/OLODATEROL HCL
    Brand/Generic Brand
    Proprietary Name Stiolto Respimat
    Proprietary Name Suffix n/a
    Non-Proprietary Name tiotropium bromide and olodaterol
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SPRAY, METERED
    Route RESPIRATORY (INHALATION)
    Active Ingredient Strength 2.736; 3.124
    Active Ingredient Units ug/1; ug/1
    Substance Name OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE MONOHYDRATE
    Labeler Name Boehringer Ingelheim Pharmaceuticals Inc.
    Pharmaceutical Class Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA206756
    Listing Certified Through 2024-12-31

    Package

    NDC 00597-0155-28 (00597015528)

    NDC Package Code 0597-0155-28
    Billing NDC 00597015528
    Package 1 CARTRIDGE in 1 CARTON (0597-0155-28) / 28 SPRAY, METERED in 1 CARTRIDGE
    Marketing Start Date 2015-05-21
    NDC Exclude Flag N
    Pricing Information N/A