Search by Drug Name or NDC

    NDC 63187-0601-14 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 Proficient Rx LP. The primary component is LORATADINE.

    Product Information

    NDC 63187-0601
    Product ID 63187-601_d36424c7-b438-4c23-884d-d4bfdac81fcf
    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 antihistamine
    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 Proficient Rx LP
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076301
    Listing Certified Through 2024-12-31

    Package

    NDC 63187-0601-14 (63187060114)

    NDC Package Code 63187-601-14
    Billing NDC 63187060114
    Package 14 TABLET in 1 BOTTLE (63187-601-14)
    Marketing Start Date 2017-08-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e9b87f79-ebed-4677-8e50-00cb4282ee56 Details

    Revised: 4/2022