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    NDC 69097-0964-53 VIGABATRIN 500 mg/mL Details

    VIGABATRIN 500 mg/mL

    VIGABATRIN is a ORAL POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA, Inc.. The primary component is VIGABATRIN.

    Product Information

    NDC 69097-0964
    Product ID 69097-964_4cdad60f-7614-47cb-8594-3c0257e55c28
    Associated GPIs 72170085003020
    GCN Sequence Number 017869
    GCN Sequence Number Description vigabatrin POWD PACK 500 MG ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 64314
    HICL Sequence Number 007377
    HICL Sequence Number Description VIGABATRIN
    Brand/Generic Generic
    Proprietary Name VIGABATRIN
    Proprietary Name Suffix n/a
    Non-Proprietary Name vigabatrin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form POWDER, FOR SOLUTION
    Route ORAL
    Active Ingredient Strength 500
    Active Ingredient Units mg/mL
    Substance Name VIGABATRIN
    Labeler Name Cipla USA, Inc.
    Pharmaceutical Class Anti-epileptic Agent [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA211592
    Listing Certified Through 2024-12-31

    Package

    NDC 69097-0964-53 (69097096453)

    NDC Package Code 69097-964-53
    Billing NDC 69097096453
    Package 50 PACKET in 1 CARTON (69097-964-53) / 10 mL in 1 PACKET
    Marketing Start Date 2019-12-04
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 823cc915-0350-4780-85ed-cd1c338e429d Details

    Revised: 5/2022