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    NDC 63187-0829-10 Promethazine Hydrochloride 25 mg/1 Details

    Promethazine Hydrochloride 25 mg/1

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

    Product Information

    NDC 63187-0829
    Product ID 63187-829_a31e8f85-d588-4653-abf6-efe03da4149c
    Associated GPIs 41400020100310
    GCN Sequence Number 003878
    GCN Sequence Number Description promethazine HCl TABLET 25 MG ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 15043
    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 25
    Active Ingredient Units mg/1
    Substance Name PROMETHAZINE HYDROCHLORIDE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Phenothiazine [EPC], Phenothiazines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA083426
    Listing Certified Through 2024-12-31

    Package

    NDC 63187-0829-10 (63187082910)

    NDC Package Code 63187-829-10
    Billing NDC 63187082910
    Package 10 TABLET in 1 BOTTLE, PLASTIC (63187-829-10)
    Marketing Start Date 2017-04-03
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 08bf9fbf-cc21-41a0-9e81-ec498aa64170 Details

    Revised: 11/2019