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    NDC 00143-9785-10 Valproate Sodium 500 mg/5mL Details

    Valproate Sodium 500 mg/5mL

    Valproate Sodium is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is VALPROATE SODIUM.

    Product Information

    NDC 00143-9785
    Product ID 0143-9785_0610e50d-6447-4a0e-bc36-dc0bffa95c7d
    Associated GPIs 72500020102020
    GCN Sequence Number 031533
    GCN Sequence Number Description valproic acid (as sodium salt) VIAL 500 MG/5ML INTRAVEN
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 64371
    HICL Sequence Number 001882
    HICL Sequence Number Description VALPROIC ACID (AS SODIUM SALT) (VALPROATE SODIUM)
    Brand/Generic Generic
    Proprietary Name Valproate Sodium
    Proprietary Name Suffix n/a
    Non-Proprietary Name Valproate Sodium
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 500
    Active Ingredient Units mg/5mL
    Substance Name VALPROATE SODIUM
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078523
    Listing Certified Through 2024-12-31

    Package

    NDC 00143-9785-10 (00143978510)

    NDC Package Code 0143-9785-10
    Billing NDC 00143978510
    Package 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9785-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9785-01)
    Marketing Start Date 2010-02-17
    NDC Exclude Flag N
    Pricing Information N/A