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    NDC 00597-0100-28 Spiriva Respimat 3.124 ug/1 Details

    Spiriva Respimat 3.124 ug/1

    Spiriva 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 ANHYDROUS.

    Product Information

    NDC 00597-0100
    Product ID 0597-0100_bf4399ac-101f-486b-8c8f-d48dffe32d63
    Associated GPIs 44100080103420
    GCN Sequence Number 063164
    GCN Sequence Number Description tiotropium bromide MIST INHAL 2.5 MCG INHALATION
    HIC3 B61
    HIC3 Description ANTICHOLINERGICS, ORALLY INHALED LONG ACTING
    GCN 98921
    HICL Sequence Number 024024
    HICL Sequence Number Description TIOTROPIUM BROMIDE
    Brand/Generic Brand
    Proprietary Name Spiriva Respimat
    Proprietary Name Suffix n/a
    Non-Proprietary Name tiotropium bromide inhalation spray
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SPRAY, METERED
    Route RESPIRATORY (INHALATION)
    Active Ingredient Strength 3.124
    Active Ingredient Units ug/1
    Substance Name TIOTROPIUM BROMIDE ANHYDROUS
    Labeler Name Boehringer Ingelheim Pharmaceuticals, Inc.
    Pharmaceutical Class Anticholinergic [EPC], Cholinergic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021936
    Listing Certified Through 2024-12-31

    Package

    NDC 00597-0100-28 (00597010028)

    NDC Package Code 0597-0100-28
    Billing NDC 00597010028
    Package 1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE
    Marketing Start Date 2014-09-30
    NDC Exclude Flag N
    Pricing Information N/A