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    NDC 63629-9151-01 PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Details

    PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL

    PROMETHAZINE HYDROCHLORIDE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is PROMETHAZINE HYDROCHLORIDE.

    Product Information

    NDC 63629-9151
    Product ID 63629-9151_0c4b71b7-0aaa-4aa0-9c8d-a0b0ad85e1ff
    Associated GPIs 41400020101210
    GCN Sequence Number 003876
    GCN Sequence Number Description promethazine HCl SYRUP 6.25MG/5ML ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 15035
    HICL Sequence Number 012014
    HICL Sequence Number Description PROMETHAZINE HCL
    Brand/Generic Generic
    Proprietary Name PROMETHAZINE HYDROCHLORIDE
    Proprietary Name Suffix n/a
    Non-Proprietary Name PROMETHAZINE HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 6.25
    Active Ingredient Units mg/5mL
    Substance Name PROMETHAZINE HYDROCHLORIDE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Phenothiazine [EPC], Phenothiazines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA040891
    Listing Certified Through 2024-12-31

    Package

    NDC 63629-9151-01 (63629915101)

    NDC Package Code 63629-9151-1
    Billing NDC 63629915101
    Package 473 mL in 1 BOTTLE (63629-9151-1)
    Marketing Start Date 2022-01-26
    NDC Exclude Flag N
    Pricing Information N/A