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    NDC 58602-0702-21 Loratadine 10 mg/1 Details

    Loratadine 10 mg/1

    Loratadine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is LORATADINE.

    Product Information

    NDC 58602-0702
    Product ID 58602-702_94169799-0508-439b-93c5-132b9e6ae767
    Associated GPIs 41550030000320
    GCN Sequence Number 018698
    GCN Sequence Number Description loratadine TABLET 10 MG ORAL
    HIC3 Z2Q
    HIC3 Description ANTIHISTAMINES - 2ND GENERATION
    GCN 60563
    HICL Sequence Number 007605
    HICL Sequence Number Description LORATADINE
    Brand/Generic Generic
    Proprietary Name Loratadine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Loratadine
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name LORATADINE
    Labeler Name Aurohealth LLC
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208314
    Listing Certified Through 2024-12-31

    Package

    NDC 58602-0702-21 (58602070221)

    NDC Package Code 58602-702-21
    Billing NDC 58602070221
    Package 1 BOTTLE in 1 CARTON (58602-702-21) / 100 TABLET in 1 BOTTLE
    Marketing Start Date 2019-12-23
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 196da80c-3dbb-40c7-ac93-8a57d6acb1c3 Details

    Revised: 8/2020