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    NDC 67457-0448-43 Famotidine 10 mg/mL Details

    Famotidine 10 mg/mL

    Famotidine is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is FAMOTIDINE.

    Product Information

    NDC 67457-0448
    Product ID 67457-448_32b0bdfe-6daf-4ec9-94c6-cdd700629263
    Associated GPIs 49200030002020
    GCN Sequence Number 011675
    GCN Sequence Number Description famotidine VIAL 10 MG/ML INTRAVEN
    HIC3 Z2D
    HIC3 Description HISTAMINE H2-RECEPTOR INHIBITORS
    GCN 46410
    HICL Sequence Number 004521
    HICL Sequence Number Description FAMOTIDINE
    Brand/Generic Generic
    Proprietary Name Famotidine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Famotidine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 10
    Active Ingredient Units mg/mL
    Substance Name FAMOTIDINE
    Labeler Name Mylan Institutional LLC
    Pharmaceutical Class Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078641
    Listing Certified Through 2024-12-31

    Package

    NDC 67457-0448-43 (67457044843)

    NDC Package Code 67457-448-43
    Billing NDC 67457044843
    Package 10 VIAL in 1 CARTON (67457-448-43) / 4 mL in 1 VIAL (67457-448-00)
    Marketing Start Date 2008-06-26
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e3b13e23-122b-4bd4-95cf-b5a14b7afc05 Details

    Revised: 8/2020