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    NDC 00641-6166-10 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 00641-6166
    Product ID 0641-6166_c33d2645-5b58-4c87-9f7b-ed2267ff9030
    Associated GPIs 07000010102013
    GCN Sequence Number 066450
    GCN Sequence Number Description amikacin sulfate VIAL 1000MG/4ML INJECTION
    HIC3 W1F
    HIC3 Description AMINOGLYCOSIDE ANTIBIOTICS
    GCN 28734
    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 00641-6166-10 (00641616610)

    NDC Package Code 0641-6166-10
    Billing NDC 00641616610
    Package 10 VIAL in 1 CARTON (0641-6166-10) / 4 mL in 1 VIAL (0641-6166-01)
    Marketing Start Date 2015-08-01
    NDC Exclude Flag N
    Pricing Information N/A