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    NDC 66288-7100-01 Vancomycin Hydrochloride 100 g/1 Details

    Vancomycin Hydrochloride 100 g/1

    Vancomycin Hydrochloride is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by SAMSON MEDICAL TECHNOLOGIES LLC. The primary component is VANCOMYCIN HYDROCHLORIDE.

    Product Information

    NDC 66288-7100
    Product ID 66288-7100_d607785f-563a-4816-83c4-dfc38bbc29bd
    Associated GPIs 16280080102145
    GCN Sequence Number 077208
    GCN Sequence Number Description vancomycin HCl BULKBAGINJ 100 G INJECTION
    HIC3 W1J
    HIC3 Description VANCOMYCIN ANTIBIOTICS AND DERIVATIVES
    GCN 43127
    HICL Sequence Number 004042
    HICL Sequence Number Description VANCOMYCIN HCL
    Brand/Generic Generic
    Proprietary Name Vancomycin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Vancomycin Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 100
    Active Ingredient Units g/1
    Substance Name VANCOMYCIN HYDROCHLORIDE
    Labeler Name SAMSON MEDICAL TECHNOLOGIES LLC
    Pharmaceutical Class Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091532
    Listing Certified Through 2024-12-31

    Package

    NDC 66288-7100-01 (66288710001)

    NDC Package Code 66288-7100-1
    Billing NDC 66288710001
    Package 1 BAG in 1 BAG (66288-7100-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG
    Marketing Start Date 2016-06-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 93589e71-3a11-4797-9176-8abdb7674a87 Details

    Revised: 11/2020