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    NDC 00143-9298-10 Sodium Ferric Gluconate Complex in Sucrose 12.5 mg/mL Details

    Sodium Ferric Gluconate Complex in Sucrose 12.5 mg/mL

    Sodium Ferric Gluconate Complex in Sucrose is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is SODIUM FERRIC GLUCONATE COMPLEX.

    Product Information

    NDC 00143-9298
    Product ID 0143-9298_4272216c-1e53-4180-a731-0592e772666f
    Associated GPIs 82300085102020
    GCN Sequence Number 067223
    GCN Sequence Number Description sodium ferric gluconat/sucrose VIAL 62.5MG/5ML INTRAVEN
    HIC3 C3B
    HIC3 Description IRON REPLACEMENT
    GCN 29727
    HICL Sequence Number 019948
    HICL Sequence Number Description SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
    Brand/Generic Generic
    Proprietary Name Sodium Ferric Gluconate Complex in Sucrose
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sodium Ferric Gluconate Complex in Sucrose
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 12.5
    Active Ingredient Units mg/mL
    Substance Name SODIUM FERRIC GLUCONATE COMPLEX
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078215
    Listing Certified Through 2024-12-31

    Package

    NDC 00143-9298-10 (00143929810)

    NDC Package Code 0143-9298-10
    Billing NDC 00143929810
    Package 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)
    Marketing Start Date 2011-03-31
    NDC Exclude Flag N
    Pricing Information N/A