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    NDC 00641-6167-10 Amikacin Sulfate 250 mg/mL Details

    Amikacin Sulfate 250 mg/mL

    Amikacin Sulfate 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 AMIKACIN SULFATE.

    Product Information

    NDC 00641-6167
    Product ID 0641-6167_c33d2645-5b58-4c87-9f7b-ed2267ff9030
    Associated GPIs 07000010102011
    GCN Sequence Number 066447
    GCN Sequence Number Description amikacin sulfate VIAL 500 MG/2ML INJECTION
    HIC3 W1F
    HIC3 Description AMINOGLYCOSIDE ANTIBIOTICS
    GCN 28729
    HICL Sequence Number 004035
    HICL Sequence Number Description AMIKACIN SULFATE
    Brand/Generic Generic
    Proprietary Name Amikacin Sulfate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amikacin Sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 250
    Active Ingredient Units mg/mL
    Substance Name AMIKACIN SULFATE
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA063315
    Listing Certified Through 2024-12-31

    Package

    NDC 00641-6167-10 (00641616710)

    NDC Package Code 0641-6167-10
    Billing NDC 00641616710
    Package 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6167-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6167-01)
    Marketing Start Date 2015-08-01
    NDC Exclude Flag N
    Pricing Information N/A