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    NDC 76420-0259-05 Gabapentin 100 mg/1 Details

    Gabapentin 100 mg/1

    Gabapentin is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is GABAPENTIN.

    Product Information

    NDC 76420-0259
    Product ID 76420-259_e6556af1-c426-5e24-e053-2995a90ae528
    Associated GPIs
    GCN Sequence Number 021413
    GCN Sequence Number Description gabapentin CAPSULE 100 MG ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 00780
    HICL Sequence Number 008831
    HICL Sequence Number Description GABAPENTIN
    Brand/Generic Generic
    Proprietary Name Gabapentin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Gabapentin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name GABAPENTIN
    Labeler Name Asclemed USA, Inc.
    Pharmaceutical Class Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204989
    Listing Certified Through 2024-12-31

    Package

    NDC 76420-0259-05 (76420025905)

    NDC Package Code 76420-259-05
    Billing NDC 76420025905
    Package 500 CAPSULE in 1 BOTTLE, PLASTIC (76420-259-05)
    Marketing Start Date 2022-08-16
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 9a829dc3-b2d8-4d19-a579-0597217cec9b Details

    Revised: 8/2022