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    NDC 65862-0107-01 Zidovudine 100 mg/1 Details

    Zidovudine 100 mg/1

    Zidovudine is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ZIDOVUDINE.

    Product Information

    NDC 65862-0107
    Product ID 65862-107_4b4bd620-4095-4719-8285-4a15760f3d8c
    Associated GPIs 12108085000110
    GCN Sequence Number 009632
    GCN Sequence Number Description zidovudine CAPSULE 100 MG ORAL
    HIC3 W5J
    HIC3 Description ANTIVIRALS, HIV-SPECIFIC, NUCLEOSIDE ANALOG, RTI
    GCN 44530
    HICL Sequence Number 004185
    HICL Sequence Number Description ZIDOVUDINE
    Brand/Generic Generic
    Proprietary Name Zidovudine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Zidovudine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name ZIDOVUDINE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078128
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0107-01 (65862010701)

    NDC Package Code 65862-107-01
    Billing NDC 65862010701
    Package 100 CAPSULE in 1 BOTTLE (65862-107-01)
    Marketing Start Date 2006-03-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf Details

    Revised: 2/2022