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    NDC 63323-0664-16 Diphenhydramine 50 mg/mL Details

    Diphenhydramine 50 mg/mL

    Diphenhydramine is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

    Product Information

    NDC 63323-0664
    Product ID 63323-664_971612e7-9b94-1822-e053-2a95a90afdf9
    Associated GPIs 41200030102010
    GCN Sequence Number 011590
    GCN Sequence Number Description diphenhydramine HCl VIAL 50 MG/ML INJECTION
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 46013
    HICL Sequence Number 004480
    HICL Sequence Number Description DIPHENHYDRAMINE HCL
    Brand/Generic Generic
    Proprietary Name Diphenhydramine
    Proprietary Name Suffix n/a
    Non-Proprietary Name DIPHENHYDRAMINE HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name DIPHENHYDRAMINE HYDROCHLORIDE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA040466
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0664-16 (63323066416)

    NDC Package Code 63323-664-16
    Billing NDC 63323066416
    Package 25 VIAL in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41)
    Marketing Start Date 2002-08-01
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.85536
    Pricing Unit ML
    Effective Date 2022-11-23
    NDC Description DIPHENHYDRAMINE 50 MG/ML VIAL
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1, 5
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 921b9f64-1096-46db-866a-67f0f9ff6790 Details

    Revised: 11/2019