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    NDC 00641-6139-25 Phenytoin Sodium 50 mg/mL Details

    Phenytoin Sodium 50 mg/mL

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

    Product Information

    NDC 00641-6139
    Product ID 0641-6139_f5296c06-aa87-4f8f-ac34-06bdad7ffa51
    Associated GPIs 72200030052005
    GCN Sequence Number 004528
    GCN Sequence Number Description phenytoin sodium VIAL 50 MG/ML INTRAVEN
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 17200
    HICL Sequence Number 001878
    HICL Sequence Number Description PHENYTOIN SODIUM
    Brand/Generic Generic
    Proprietary Name Phenytoin Sodium
    Proprietary Name Suffix n/a
    Non-Proprietary Name Phenytoin Sodium
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name PHENYTOIN SODIUM
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA084307
    Listing Certified Through 2024-12-31

    Package

    NDC 00641-6139-25 (00641613925)

    NDC Package Code 0641-6139-25
    Billing NDC 00641613925
    Package 25 VIAL in 1 CARTON (0641-6139-25) / 5 mL in 1 VIAL (0641-6139-01)
    Marketing Start Date 1975-07-16
    NDC Exclude Flag N
    Pricing Information N/A