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    NDC 68094-0123-62 Oxcarbazepine 300 mg/5mL Details

    Oxcarbazepine 300 mg/5mL

    Oxcarbazepine is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Precision Dose, Inc.. The primary component is OXCARBAZEPINE.

    Product Information

    NDC 68094-0123
    Product ID 68094-123_43ea970d-701d-409d-b9a1-4e0c171ede4d
    Associated GPIs 72600046001820
    GCN Sequence Number 033724
    GCN Sequence Number Description oxcarbazepine ORAL SUSP 300 MG/5ML ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 21723
    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 SUSPENSION
    Route ORAL
    Active Ingredient Strength 300
    Active Ingredient Units mg/5mL
    Substance Name OXCARBAZEPINE
    Labeler Name Precision Dose, Inc.
    Pharmaceutical Class Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202961
    Listing Certified Through 2024-12-31

    Package

    NDC 68094-0123-62 (68094012362)

    NDC Package Code 68094-123-62
    Billing NDC 68094012362
    Package 3 TRAY in 1 CASE (68094-123-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)
    Marketing Start Date 2017-09-13
    NDC Exclude Flag N
    Pricing Information N/A