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    NDC 50383-0805-04 promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Details

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

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

    Product Information

    NDC 50383-0805
    Product ID 50383-805_9d5b76d0-633e-44f1-b1e1-63efab89626d
    Associated GPIs 43995303101210
    GCN Sequence Number 048496
    GCN Sequence Number Description promethazine/phenyleph/codeine SYRUP 6.25-5-10 ORAL
    HIC3 B3Q
    HIC3 Description OPIOID ANTITUSSIV-1ST GEN. ANTIHISTAMINE-DECONGEST
    GCN 13978
    HICL Sequence Number 000420
    HICL Sequence Number Description PROMETHAZINE/PHENYLEPHRINE HCL/CODEINE
    Brand/Generic Generic
    Proprietary Name promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate
    Proprietary Name Suffix n/a
    Non-Proprietary Name promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 10; 5; 6.25
    Active Ingredient Units mg/5mL; mg/5mL; mg/5mL
    Substance Name CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
    Labeler Name Akorn
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
    DEA Schedule CV
    Marketing Category ANDA
    Application Number ANDA040674
    Listing Certified Through 2024-12-31

    Package

    NDC 50383-0805-04 (50383080504)

    NDC Package Code 50383-805-04
    Billing NDC 50383080504
    Package 118 mL in 1 BOTTLE (50383-805-04)
    Marketing Start Date 2016-06-06
    NDC Exclude Flag N
    Pricing Information N/A