Search by Drug Name or NDC

    NDC 70752-0139-06 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 QUAGEN PHARMACEUTICALS LLC. The primary component is CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

    Product Information

    NDC 70752-0139
    Product ID 70752-139_ea7f15a6-079d-4146-a13d-74c129ec598e
    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 QUAGEN PHARMACEUTICALS LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
    DEA Schedule CV
    Marketing Category ANDA
    Application Number ANDA214238
    Listing Certified Through 2024-12-31

    Package

    NDC 70752-0139-06 (70752013906)

    NDC Package Code 70752-139-06
    Billing NDC 70752013906
    Package 118 mL in 1 BOTTLE, PLASTIC (70752-139-06)
    Marketing Start Date 2020-10-08
    NDC Exclude Flag N
    Pricing Information N/A