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    NDC 00597-0075-47 Spiriva 18 ug/1 Details

    Spiriva 18 ug/1

    Spiriva 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 Information

    NDC 00597-0075
    Product ID 0597-0075_74c01ed6-9299-467e-bda9-8043c8d887fb
    Associated GPIs 44100080100120
    GCN Sequence Number 050714
    GCN Sequence Number Description tiotropium bromide CAP W/DEV 18 MCG INHALATION
    HIC3 B61
    HIC3 Description ANTICHOLINERGICS, ORALLY INHALED LONG ACTING
    GCN 17853
    HICL Sequence Number 024024
    HICL Sequence Number Description TIOTROPIUM BROMIDE
    Brand/Generic Brand
    Proprietary Name Spiriva
    Proprietary Name Suffix HandiHaler
    Non-Proprietary Name TIOTROPIUM BROMIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL; RESPIRATORY (INHALATION)
    Active Ingredient Strength 18
    Active Ingredient Units ug/1
    Substance Name TIOTROPIUM BROMIDE MONOHYDRATE
    Labeler Name Boehringer Ingelheim Pharmaceuticals, Inc.
    Pharmaceutical Class Anticholinergic [EPC], Cholinergic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021395
    Listing Certified Through 2024-12-31

    Package

    NDC 00597-0075-47 (00597007547)

    NDC Package Code 0597-0075-47
    Billing NDC 00597007547
    Package 9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK
    Marketing Start Date 2005-10-11
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 15.8644
    Pricing Unit EA
    Effective Date 2022-01-10
    NDC Description SPIRIVA HANDIHALER 18 MCG CAP
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 4, 5
    Classification for Rate Setting B
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 820839ef-e53d-47e8-a3b9-d911ff92e6a9 Details

    Revised: 1/2022