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    NDC 76045-0102-10 Diphenhydramine Hydrochloride 50 mg/mL Details

    Diphenhydramine Hydrochloride 50 mg/mL

    Diphenhydramine Hydrochloride 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 76045-0102
    Product ID 76045-102_7ac2810d-c4c6-42de-8ea6-cb84002ae1e7
    Associated GPIs 41200030102010
    GCN Sequence Number 011585
    GCN Sequence Number Description diphenhydramine HCl SYRINGE 50 MG/ML INJECTION
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 46000
    HICL Sequence Number 004480
    HICL Sequence Number Description DIPHENHYDRAMINE HCL
    Brand/Generic Generic
    Proprietary Name Diphenhydramine Hydrochloride
    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 ANDA091526
    Listing Certified Through 2024-12-31

    Package

    NDC 76045-0102-10 (76045010210)

    NDC Package Code 76045-102-10
    Billing NDC 76045010210
    Package 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
    Marketing Start Date 2013-03-26
    NDC Exclude Flag N
    Pricing Information N/A