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    NDC 67877-0477-50 Azelastine 137 ug/1 Details

    Azelastine 137 ug/1

    Azelastine is a NASAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ascend Laboratories, LLC. The primary component is AZELASTINE HYDROCHLORIDE.

    Product Information

    NDC 67877-0477
    Product ID 67877-477_66c5c246-98fc-4043-b866-b264cc64f1a2
    Associated GPIs 42401015102020
    GCN Sequence Number 029893
    GCN Sequence Number Description azelastine HCl SPRAY/PUMP 137 MCG NASAL
    HIC3 Q7E
    HIC3 Description NASAL ANTIHISTAMINE
    GCN 60544
    HICL Sequence Number 007607
    HICL Sequence Number Description AZELASTINE HCL
    Brand/Generic Generic
    Proprietary Name Azelastine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Azelastine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SPRAY, METERED
    Route NASAL
    Active Ingredient Strength 137
    Active Ingredient Units ug/1
    Substance Name AZELASTINE HYDROCHLORIDE
    Labeler Name Ascend Laboratories, LLC
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208156
    Listing Certified Through 2024-12-31

    Package

    NDC 67877-0477-50 (67877047750)

    NDC Package Code 67877-477-50
    Billing NDC 67877047750
    Package 1 SPRAY, METERED in 1 BOTTLE (67877-477-50)
    Marketing Start Date 2017-08-18
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.30282
    Pricing Unit ML
    Effective Date 2022-11-23
    NDC Description AZELASTINE 0.1% (137 MCG) SPRY
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1, 5
    Classification for Rate Setting G
    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 77b20c6b-f30f-42a9-a0ef-d5d0bd3feb56 Details

    Revised: 11/2022