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    NDC 39822-0166-07 Polymyxin B 500000 [USP'U]/1 Details

    Polymyxin B 500000 [USP'U]/1

    Polymyxin B is a INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is POLYMYXIN B SULFATE.

    Product Information

    NDC 39822-0166
    Product ID 39822-0166_eedc47c0-5580-3069-e053-2995a90a0226
    Associated GPIs 16100010102105
    GCN Sequence Number 009354
    GCN Sequence Number Description polymyxin B sulfate VIAL 500K UNIT INJECTION
    HIC3 W1N
    HIC3 Description POLYMYXIN ANTIBIOTICS AND DERIVATIVES
    GCN 41320
    HICL Sequence Number 004049
    HICL Sequence Number Description POLYMYXIN B SULFATE
    Brand/Generic Generic
    Proprietary Name Polymyxin B
    Proprietary Name Suffix n/a
    Non-Proprietary Name Polymyxin B
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
    Active Ingredient Strength 500000
    Active Ingredient Units [USP'U]/1
    Substance Name POLYMYXIN B SULFATE
    Labeler Name XGen Pharmaceuticals DJB, Inc.
    Pharmaceutical Class Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA063000
    Listing Certified Through 2024-12-31

    Package

    NDC 39822-0166-07 (39822016607)

    NDC Package Code 39822-0166-7
    Billing NDC 39822016607
    Package 1 VIAL in 1 CARTON (39822-0166-7) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
    Marketing Start Date 1994-09-30
    NDC Exclude Flag N
    Pricing Information N/A