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    NDC 47335-0903-61 Quetiapine fumarate 50 mg/1 Details

    Quetiapine fumarate 50 mg/1

    Quetiapine fumarate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is QUETIAPINE FUMARATE.

    Product Information

    NDC 47335-0903
    Product ID 47335-903_7d9c9071-2f8a-471b-9e80-5d2e18cae951
    Associated GPIs 59153070100314
    GCN Sequence Number 060292
    GCN Sequence Number Description quetiapine fumarate TABLET 50 MG ORAL
    HIC3 H7T
    HIC3 Description ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST
    GCN 26409
    HICL Sequence Number 014015
    HICL Sequence Number Description QUETIAPINE FUMARATE
    Brand/Generic Generic
    Proprietary Name Quetiapine fumarate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Quetiapine fumarate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name QUETIAPINE FUMARATE
    Labeler Name Sun Pharmaceutical Industries, Inc.
    Pharmaceutical Class Atypical Antipsychotic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201190
    Listing Certified Through 2024-12-31

    Package

    NDC 47335-0903-61 (47335090361)

    NDC Package Code 47335-903-61
    Billing NDC 47335090361
    Package 10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-903-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2012-03-28
    NDC Exclude Flag N
    Pricing Information N/A