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    NDC 45865-0115-21 tramadol hydrochloride 50 mg/1 Details

    tramadol hydrochloride 50 mg/1

    tramadol hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is TRAMADOL HYDROCHLORIDE.

    Product Information

    NDC 45865-0115
    Product ID 45865-115_b53300b2-8582-284c-e053-2995a90a83d0
    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 tramadol hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name tramadol hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name TRAMADOL HYDROCHLORIDE
    Labeler Name Medsource Pharmaceuticals
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA075964
    Listing Certified Through 2024-12-31

    Package

    NDC 45865-0115-21 (45865011521)

    NDC Package Code 45865-115-21
    Billing NDC 45865011521
    Package 21 TABLET in 1 BOTTLE (45865-115-21)
    Marketing Start Date 2020-07-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL b533007a-ffe8-4de7-e053-2a95a90a1901 Details

    Revised: 11/2020