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    NDC 71205-0476-90 Levocetirizine Dihydrochloride 5 mg/1 Details

    Levocetirizine Dihydrochloride 5 mg/1

    Levocetirizine Dihydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is LEVOCETIRIZINE DIHYDROCHLORIDE.

    Product Information

    NDC 71205-0476
    Product ID 71205-476_c2d5fe36-08b4-46cc-b6d9-8663f57d56d4
    Associated GPIs 41550027100320
    GCN Sequence Number 048920
    GCN Sequence Number Description levocetirizine dihydrochloride TABLET 5 MG ORAL
    HIC3 Z2Q
    HIC3 Description ANTIHISTAMINES - 2ND GENERATION
    GCN 14901
    HICL Sequence Number 022959
    HICL Sequence Number Description LEVOCETIRIZINE DIHYDROCHLORIDE
    Brand/Generic Generic
    Proprietary Name Levocetirizine Dihydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Levocetirizine Dihydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name LEVOCETIRIZINE DIHYDROCHLORIDE
    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 ANDA203646
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0476-90 (71205047690)

    NDC Package Code 71205-476-90
    Billing NDC 71205047690
    Package 90 TABLET in 1 BOTTLE, PLASTIC (71205-476-90)
    Marketing Start Date 2020-09-23
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 7108ad0a-af1e-4172-b4ba-e5d9aaadfba7 Details

    Revised: 10/2022