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    NDC 70752-0138-06 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 QUAGEN PHARMACEUTICALS LLC. The primary component is PROMETHAZINE HYDROCHLORIDE.

    Product Information

    NDC 70752-0138
    Product ID 70752-138_63b61b41-3490-4c96-a50d-778498b51899
    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 QUAGEN PHARMACEUTICALS LLC
    Pharmaceutical Class Phenothiazine [EPC], Phenothiazines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213890
    Listing Certified Through 2024-12-31

    Package

    NDC 70752-0138-06 (70752013806)

    NDC Package Code 70752-138-06
    Billing NDC 70752013806
    Package 118 mL in 1 BOTTLE, PLASTIC (70752-138-06)
    Marketing Start Date 2021-07-12
    NDC Exclude Flag N
    Pricing Information N/A