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    NDC 64950-0343-16 Hydrocodone Bitartrate and Acetaminophen 325; 7.5 mg/15mL; mg/15mL Details

    Hydrocodone Bitartrate and Acetaminophen 325; 7.5 mg/15mL; mg/15mL

    Hydrocodone Bitartrate and Acetaminophen is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Genus Lifesciences Inc.. The primary component is ACETAMINOPHEN; HYDROCODONE BITARTRATE.

    Product Information

    NDC 64950-0343
    Product ID 64950-343_ff61229c-3028-4ac8-8aa3-5f09f05cb10e
    Associated GPIs 65991702102015
    GCN Sequence Number 053582
    GCN Sequence Number Description hydrocodone/acetaminophen SOLUTION 7.5-325/15 ORAL
    HIC3 H3U
    HIC3 Description OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS
    GCN 21146
    HICL Sequence Number 001730
    HICL Sequence Number Description HYDROCODONE BITARTRATE/ACETAMINOPHEN
    Brand/Generic Generic
    Proprietary Name Hydrocodone Bitartrate and Acetaminophen
    Proprietary Name Suffix n/a
    Non-Proprietary Name hydrocodone bitartrate and acetaminophen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 325; 7.5
    Active Ingredient Units mg/15mL; mg/15mL
    Substance Name ACETAMINOPHEN; HYDROCODONE BITARTRATE
    Labeler Name Genus Lifesciences Inc.
    Pharmaceutical Class Opioid Agonist [EPC], Opioid Agonists [MoA]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA040894
    Listing Certified Through 2024-12-31

    Package

    NDC 64950-0343-16 (64950034316)

    NDC Package Code 64950-343-16
    Billing NDC 64950034316
    Package 473 mL in 1 BOTTLE (64950-343-16)
    Marketing Start Date 2020-11-20
    NDC Exclude Flag N
    Pricing Information N/A