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    NDC 70408-0185-34 promethazine hydrochloride and codeine phosphate 10; 6.25 mg/5mL; mg/5mL Details

    promethazine hydrochloride and codeine phosphate 10; 6.25 mg/5mL; mg/5mL

    promethazine hydrochloride and codeine phosphate is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nostrum Laboratories, Inc.. The primary component is CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

    Product Information

    NDC 70408-0185
    Product ID 70408-185_e78195f4-5ace-42b1-b42b-df1546e5b596
    Associated GPIs 43995202341210
    GCN Sequence Number 048489
    GCN Sequence Number Description promethazine HCl/codeine SYRUP 6.25-10/5 ORAL
    HIC3 B4D
    HIC3 Description OPIOID ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE
    GCN 13971
    HICL Sequence Number 000345
    HICL Sequence Number Description PROMETHAZINE HCL/CODEINE
    Brand/Generic Generic
    Proprietary Name promethazine hydrochloride and codeine phosphate
    Proprietary Name Suffix n/a
    Non-Proprietary Name promethazine hydrochloride and codeine phosphate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 10; 6.25
    Active Ingredient Units mg/5mL; mg/5mL
    Substance Name CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
    Labeler Name Nostrum Laboratories, Inc.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
    DEA Schedule CV
    Marketing Category ANDA
    Application Number ANDA090180
    Listing Certified Through 2024-12-31

    Package

    NDC 70408-0185-34 (70408018534)

    NDC Package Code 70408-185-34
    Billing NDC 70408018534
    Package 473 mL in 1 BOTTLE (70408-185-34)
    Marketing Start Date 2010-03-17
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 14f50f2c-ee0e-4345-b6c6-80bd50171772 Details

    Revised: 5/2018