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    NDC 70069-0801-25 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 Somerset Therapeutics, LLC. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 70069-0801
    Product ID 70069-801_90a3853e-49d6-4536-be72-82cc875bcf74
    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 Somerset Therapeutics, LLC
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213318
    Listing Certified Through 2024-12-31

    Package

    NDC 70069-0801-25 (70069080125)

    NDC Package Code 70069-801-25
    Billing NDC 70069080125
    Package 25 VIAL in 1 CARTON (70069-801-25) / 1 mL in 1 VIAL (70069-801-01)
    Marketing Start Date 2021-09-22
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 90a3853e-49d6-4536-be72-82cc875bcf74 Details

    Revised: 9/2021