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    NDC 16729-0465-03 Phenylephrine hydrochloride 10 mg/mL Details

    Phenylephrine hydrochloride 10 mg/mL

    Phenylephrine hydrochloride is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 16729-0465
    Product ID 16729-465_f9b4f7dc-ca9a-858c-e053-6394a90aff51
    Associated GPIs 38000095102020
    GCN Sequence Number 005068
    GCN Sequence Number Description phenylephrine HCl VIAL 10 MG/ML INJECTION
    HIC3 J5E
    HIC3 Description SYMPATHOMIMETIC AGENTS
    GCN 20310
    HICL Sequence Number 002087
    HICL Sequence Number Description PHENYLEPHRINE HCL
    Brand/Generic Generic
    Proprietary Name Phenylephrine hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Phenylephrine hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 10
    Active Ingredient Units mg/mL
    Substance Name PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name Accord Healthcare, Inc.
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213237
    Listing Certified Through 2024-12-31

    Package

    NDC 16729-0465-03 (16729046503)

    NDC Package Code 16729-465-03
    Billing NDC 16729046503
    Package 10 CARTON in 1 CARTON (16729-465-03) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-465-31) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE
    Marketing Start Date 2022-03-11
    NDC Exclude Flag N
    Pricing Information N/A