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    NDC 00121-0925-16 Promethazine VC with Codeine Oral Solution 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Details

    Promethazine VC with Codeine Oral Solution 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL

    Promethazine VC with Codeine Oral Solution is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE.

    Product Information

    NDC 00121-0925
    Product ID 0121-0925_6468c79b-ff80-4d93-ad5a-7a63f54b5c70
    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 VC with Codeine Oral Solution
    Proprietary Name Suffix n/a
    Non-Proprietary Name Promethazine and 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 PAI Holdings, LLC
    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 ANDA040660
    Listing Certified Through 2024-12-31

    Package

    NDC 00121-0925-16 (00121092516)

    NDC Package Code 0121-0925-16
    Billing NDC 00121092516
    Package 473 mL in 1 BOTTLE (0121-0925-16)
    Marketing Start Date 2021-03-18
    NDC Exclude Flag N
    Pricing Information N/A