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    NDC 50383-0942-30 Azelastine Hydrochloride 1.5 mg/mL Details

    Azelastine Hydrochloride 1.5 mg/mL

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

    Product Information

    NDC 50383-0942
    Product ID 50383-942_fb3b3cc4-5848-4e70-8373-0d8a9e613e20
    Associated GPIs 42401015102030
    GCN Sequence Number 065577
    GCN Sequence Number Description azelastine HCl SPRAY/PUMP 205.5 MCG NASAL
    HIC3 Q7E
    HIC3 Description NASAL ANTIHISTAMINE
    GCN 27584
    HICL Sequence Number 007607
    HICL Sequence Number Description AZELASTINE HCL
    Brand/Generic Generic
    Proprietary Name Azelastine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Azelastine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SPRAY, METERED
    Route NASAL
    Active Ingredient Strength 1.5
    Active Ingredient Units mg/mL
    Substance Name AZELASTINE HYDROCHLORIDE
    Labeler Name Akorn
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210032
    Listing Certified Through 2023-12-31

    Package

    NDC 50383-0942-30 (50383094230)

    NDC Package Code 50383-942-30
    Billing NDC 50383094230
    Package 1 BOTTLE, PUMP in 1 CARTON (50383-942-30) / 30 mL in 1 BOTTLE, PUMP
    Marketing Start Date 2019-08-27
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.83075
    Pricing Unit ML
    Effective Date 2022-11-23
    NDC Description AZELASTINE 0.15% NASAL SPRAY
    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 fc69f672-17ec-4d86-b5af-086fd260b512 Details

    Revised: 3/2022