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    NDC 70069-0091-01 Azelastine Hydrochloride 0.5 mg/mL Details

    Azelastine Hydrochloride 0.5 mg/mL

    Azelastine Hydrochloride is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Somerset Therapeutics, LLC. The primary component is AZELASTINE HYDROCHLORIDE.

    Product Information

    NDC 70069-0091
    Product ID 70069-091_99a056e5-2dcd-4102-8132-55bf9b3ba069
    Associated GPIs 86802006102020
    GCN Sequence Number 040646
    GCN Sequence Number Description azelastine HCl DROPS 0.05 % OPHTHALMIC
    HIC3 Q6R
    HIC3 Description EYE ANTIHISTAMINES
    GCN 94615
    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 SOLUTION/ DROPS
    Route OPHTHALMIC
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/mL
    Substance Name AZELASTINE HYDROCHLORIDE
    Labeler Name Somerset Therapeutics, LLC
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207411
    Listing Certified Through 2024-12-31

    Package

    NDC 70069-0091-01 (70069009101)

    NDC Package Code 70069-091-01
    Billing NDC 70069009101
    Package 1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE
    Marketing Start Date 2019-04-08
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 1.14907
    Pricing Unit ML
    Effective Date 2022-11-23
    NDC Description AZELASTINE HCL 0.05% DROPS
    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