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    NDC 71205-0449-30 Azelastine Hydrochloride 137 ug/1 Details

    Azelastine Hydrochloride 137 ug/1

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

    Product Information

    NDC 71205-0449
    Product ID 71205-449_91c72454-515f-4966-ad84-a78aba616fb5
    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 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 137
    Active Ingredient Units ug/1
    Substance Name AZELASTINE HYDROCHLORIDE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077954
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0449-30 (71205044930)

    NDC Package Code 71205-449-30
    Billing NDC 71205044930
    Package 1 BOTTLE, SPRAY in 1 CARTON (71205-449-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
    Marketing Start Date 2020-04-01
    NDC Exclude Flag N
    Pricing Information N/A