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    NDC 68462-0138-05 Oxcarbazepine 300 mg/1 Details

    Oxcarbazepine 300 mg/1

    Oxcarbazepine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is OXCARBAZEPINE.

    Product Information

    NDC 68462-0138
    Product ID 68462-138_a47a76fe-644a-48a7-b41b-062961a7d7ef
    Associated GPIs 72600046000320
    GCN Sequence Number 027779
    GCN Sequence Number Description oxcarbazepine TABLET 300 MG ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 21721
    HICL Sequence Number 011735
    HICL Sequence Number Description OXCARBAZEPINE
    Brand/Generic Generic
    Proprietary Name Oxcarbazepine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Oxcarbazepine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 300
    Active Ingredient Units mg/1
    Substance Name OXCARBAZEPINE
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077802
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0138-05 (68462013805)

    NDC Package Code 68462-138-05
    Billing NDC 68462013805
    Package 500 TABLET, FILM COATED in 1 BOTTLE (68462-138-05)
    Marketing Start Date 2007-10-09
    NDC Exclude Flag N
    Pricing Information N/A