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    NDC 45865-0985-90 Metaxalone 800 mg/1 Details

    Metaxalone 800 mg/1

    Metaxalone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by medsource pharmaceuticals. The primary component is METAXALONE.

    Product Information

    NDC 45865-0985
    Product ID 45865-985_9af18dc9-fcef-fde1-e053-2995a90a4087
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Metaxalone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Metaxalone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 800
    Active Ingredient Units mg/1
    Substance Name METAXALONE
    Labeler Name medsource pharmaceuticals
    Pharmaceutical Class Centrally-mediated Muscle Relaxation [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203695
    Listing Certified Through 2024-12-31

    Package

    NDC 45865-0985-90 (45865098590)

    NDC Package Code 45865-985-90
    Billing NDC 45865098590
    Package 90 TABLET in 1 BOTTLE (45865-985-90)
    Marketing Start Date 2019-12-11
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 9af17dc7-04cd-de48-e053-2995a90a8709 Details

    Revised: 12/2019