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    NDC 71205-0205-90 Sertraline Hydrochloride 50 mg/1 Details

    Sertraline Hydrochloride 50 mg/1

    Sertraline Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is SERTRALINE HYDROCHLORIDE.

    Product Information

    NDC 71205-0205
    Product ID 71205-205_989d7e7a-1918-40f2-a3b1-c637f4a8fad2
    Associated GPIs 58160070100310
    GCN Sequence Number 046228
    GCN Sequence Number Description sertraline HCl TABLET 50 MG ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 16374
    HICL Sequence Number 006324
    HICL Sequence Number Description SERTRALINE HCL
    Brand/Generic Generic
    Proprietary Name Sertraline Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sertraline Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name SERTRALINE HYDROCHLORIDE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077206
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0205-90 (71205020590)

    NDC Package Code 71205-205-90
    Billing NDC 71205020590
    Package 90 TABLET, FILM COATED in 1 BOTTLE (71205-205-90)
    Marketing Start Date 2007-02-06
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a0b4b9c9-bd5b-4900-8abf-b55d3283c53c Details

    Revised: 4/2022