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    NDC 61919-0047-10 PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Details

    PROMETHAZINE HYDROCHLORIDE 12.5 mg/1

    PROMETHAZINE HYDROCHLORIDE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Direct Rx. The primary component is PROMETHAZINE HYDROCHLORIDE.

    Product Information

    NDC 61919-0047
    Product ID 61919-047_f8231806-ab1c-78b8-e053-6294a90a593f
    Associated GPIs 41400020100305
    GCN Sequence Number 003877
    GCN Sequence Number Description promethazine HCl TABLET 12.5 MG ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 15042
    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 TABLET
    Route ORAL
    Active Ingredient Strength 12.5
    Active Ingredient Units mg/1
    Substance Name PROMETHAZINE HYDROCHLORIDE
    Labeler Name Direct Rx
    Pharmaceutical Class Phenothiazine [EPC], Phenothiazines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091179
    Listing Certified Through 2024-12-31

    Package

    NDC 61919-0047-10 (61919004710)

    NDC Package Code 61919-047-10
    Billing NDC 61919004710
    Package 10 TABLET in 1 BOTTLE (61919-047-10)
    Marketing Start Date 2018-03-14
    NDC Exclude Flag N
    Pricing Information N/A